It is a while since we last reported on Contrave, the experimental weight loss medication concocted by Orexigen Therapeutics from two existing medications: bupropion and naltrexone.  The medication met the FDA’s minimum efficacy requirements for a weight loss medication, even although the results were not staggering. At the end of the day however, the FDA declined to provide a license and asked the company to conduct exhaustive cardiovascular studies, which are now under way.

There really is a dearth of weight loss medications available for us to prescribe for obese or overweight patients, so we are more than happy to hear that the European Medicines Agency has been constructive in its approach to Contrave and Orexigen intends to submit a Marketing Authorization Application in the next few months. The company should have interim results from its cardiovascular study by the time of the 120 day questions from the European Medicines Agency and it seems that these interim results will be acceptable to the agency in terms of taking the application forward.

With Qsiva being rejected by the EMA and Lorcaserin running out of time and being voluntarily withdrawn, let’s hope that Contrave fairs better. You can read more about Contrave here.

We previously reported that Contrave could gain approval from the FDA if Orexigen Therapeutics were able to demonstrate in a clinical trial that the treatment was not related to cardiovascular problems. Orexigen has now stated that recent discussions with the FDA have made them optimistic about the possibility of accelerating the regulatory review that is required before the treatment is approved.

The purpose of the trial, which has been referred to as The Light Study, is to evaluate whether individuals taking Contrave will develop any Major Adverse Cardiovascular Events (MACE) that individuals taking placebo medication do not develop or if there is any statistically significant difference in the incidence of such events between the two groups. Although the complete trial is likely to take a long time, the goal is to release an interim analysis of the data once the 87^th MACE has occurred. To date 7000 individuals have been recruited and the aim is to recruit 9000 individuals before the end of this year. By having an increased rate of enrolment, the hope is that the interim analysis can be moved by up to two months.

Orexigen is prepared to resubmit the new drug application before the interim assessment, and then provide the analysis while the drug application is pending. If the FDA agrees to this, then it is possible that the review of their application could begin weeks or months before the interim analysis has been completed. This would of course be a valuable head start, as a standard review period for a medication is usually 10 months long.

Despite the fact that trials are both time-consuming and expensive, Orexigen is yet to abandon hope on getting approval for Contrave. We believe that this is a reflection of the fact that the noted cardiovascular risks in the past were not significant for the company to abandon the expensive quest to get Contrave approved.

A team of researchers at Harvard Medical School claim they have created a pill that has the same effect on the body as exercise does without requiring us to move a muscle. They are looking into the creation of a pill form of irisin, a hormone that is made naturally in the body during exercise.

It has been suggested that irisin, which is found in muscle cells, and known to spur on the burning of calories during exercise, could potentially become a treatment for obesity. We know that the level of this hormone in the body increases while we exercise and in turn helps to control blood sugar levels and increases the amount of energy we expend and the team suggests that the drug could potentially be used to treat diabetes and even cancer. The study is published online in Nature.

Consuming the pill form of this hormone would help the body to produce healthy brown fat, which in turn helps us to lose weight. Unfortunately we have less brown fat as we get older since white fat replaces brown fat as we age and is typically deposited around the waist.

In order to examine whether or not an increase in irisin could produce the same effects that exercise would, obese, pre-diabetic, sedentary mice were injected with small amounts of irisin and after 10 days the mice gained control over blood glucose levels and lost a modest amount of weight. The study’s author suggests that a greater amount of weight would have been lost if the hormone had been administered over a longer period of time.

This is a very interesting development but please don’t sit around waiting for this pill to be licensed. You are going to need to join a gym and shake that booty if you are going to shift those extra pounds!

The Food and Drug Administration in the USA has accepted Vivus’s new drug application for the approval of their obesity drug, Qnexa, which will assist with weight loss in obese patients with a BMI of greater than 30 or patients who are overweight with a BMI of greater than 27 and with other health complications that stem from their weight. The FDA has set a target date of the 17^th April of next year for this application.

The treatment will also be suitable for patients who suffer from illnesses or conditions associated with their weight such as type-2 diabetes. The drug is not suitable for women of a childbearing age at the current time, pending further investigations to ascertain whether there is an association between topiramate and birth defects. The application will be discussed in the first quarter of next year.

Qnexa is now the closest weight loss drug to the finish line. This is an exciting time for Vivus, which has been hoping to have their phentermine/topiramate combination on the market for some time now. The pharmaceutical company also submitted a marketing authorization application with the European Medicines Agency in 2010. A decision is expected at the end of this year on this matter. Given the dearth of treatment options available, there is a dire need for some sort of medication to give patients the help that they need to get the weight off. The questions will be whether they can keep the weight off after they come off the medication.

There might be light at the end of the tunnel for Orexigen Therapeutics yet with their weight loss drug, Contrave. Having been rejected for approval in February, the Food and Drug Administration in the States has said that they will reconsider the approval of the drug if a clinical trial can prove that the drug is not linked with cardiovascular problems. In previous trials, increases in blood pressure and pulse rates were noted.

The company is confident that they will pull this off and proceed with the trial trial despite the possibility that the trial could last a number of years. Both ingredients in Contrave are available separately on the market: bupropion and naltrexone. These drugs serve to increase the levels of dopamine, serotonin and norepinephrine in the brain. Both drugs in combination quell the appetite and cause the body’s metabolism to speed up.

Previous trials have shown that 50% of those taking the drug were able to lose 5% of their original body weight over the period of one year and this was compared to 10% from a placebo control group which managed the same degree of weight loss.

It is still a tense time for pharmaceutical companies who are eager to produce an alternative weight loss treatment to Xenical but Arena Pharmaceuticals Inc. have proved the Food and Drug Administration (U.S) wrong regarding their suspicions of Lorcaserin’s connection with cancer risk and heart valve damage and so hope is rekindled in the search for a potentially effective drug for weight loss.

A recent clinical trial carried out by the company reveals that only a moderate weight loss was observed with patients taking their weight loss drug hopeful, Lorcaserin, however with no serious adverse sidebeffects or heart related damage. 4,000 obese adults participated in the study which was carried out over a period of one year and 40% of participants lost at least 5% of their initial body weight . Only 25% of those taking the placebo experienced the same results.

The study’s author expresses that although the weight lost was moderate, it would still have a substantial effect on obesity related health problems. There is a worry that the Food and Drug Administration are being too strict on such pharmaceutical companies and in the meantime people are seriously overweight and without drug options.

In February this year Orexigen was asked by the FDA (Food and Drug Administration) to carry out a sizable trial to evaluate the potential cardiovascular risks involved with taking its weight loss drug candidate, Contrave.

Orexigen recently asked the FDA if Contrave could be approved for patients with low cardiovascular risk. The FDA decided that they wanted to see the results of a pre-approval cardiovascular outcomes trial and that Orexigen’s proposal did not meet their objectives - much to the irritation of Orexigen, which feels that the amount of information requested is unnecessary and also difficult to complile. Even if the pharmaceutical company goes ahead with the trial, the potential agreement reached may be scrapped shortly thereafter considering that the FDA’s DMEP (Division of Metabolic and Endocrinologic Products) has decided to hold an advisory committee meeting next year to lay down ground rules for cardiovascular assessment relating to pre-approval obesity treatments.

The company has stalled further development of Contrave in the USA until they are given a clear path to regulatory approval. Orexigen has stated that it intends to accelerate its programme to get Contrave licensed in other territories and we believe that will include the EU so this could be good news for obese patients in Europe.

In the latest Qnexa news, some exciting results have been published in the Journal of the American Medical Association which Vivus, Qnexa’s creators, hope will win them the approval of the FDA (Food and Drug Administration). It was the first population based study carried out on the risk of birth defects from anti-epileptic treatment, topiramate, a key ingredient in this weight loss treatment hopeful.

This was a large scale study based on data collected between 1996 and 2008 which looked at 838,000 births in Denmark where mothers had taken topiramate and it was discovered that topiramate did not increase the occurrence of birth defects to any significant level.

Presently, Vivus is carrying out a trial based on recent but existing data which will study the children of mothers who took topiramate. Vivus recently requested that their drug be approved for those who cannot have children but if similar results are collected in this present study, Qnexa might be approved for all obese and overweight men and women.

Vivus will be resubmitting an application to the FDA for the approval of its weight loss drug, Qnexa in the fourth quarter of this year. Vivus hopes that the new application will be approved so they can market the drug as a weight loss treatment for people who are no longer able to bear children.

The main reason Qnexa was refused in October by the FDA (Food and Drug Administration) in the US, was down to the possible risk of birth defects due to evidence surrounding birth defects in children born of women who had in the past taken Topiramate, one of the two active ingredients in Qnexa. Vivus will be carrying out a retrospective study on this in order to quash the concerns of the agency.

The application to market the drug to those who cannot bear children is likely to have a positive outcome according to analysts.

Experts on obesity including representatives of the Obesity Society and the American Society for Metabolic and Bariatric Surgery, to name but a few organisations involved, met with an FDA (Food and Drug Administration) spokesperson on Tuesday to discuss the future of the weight loss drug market as prompted by the rejection of three hopeful weight loss drugs this last 6 months, Contrave, Qnexa and Lorcaserin. Contrave was the closest to the finish line with the advisory panel recommending the approval of the drug. The FDA rejected the drug in the end despite normally going with the advice of its panel because they said they required more information on cardiovascular outcomes.

The spokesperson for the FDA was clear about the requirements for the approval of weight loss drugs and stated that in clinical trials, pharmaceutical companies must show that 30% of people at least lose 5% of body weight. Furthermore, one year later, the deviation in the mean weight loss between the control group and the group taking the drug must be at least 5%.

She went on to say that a 5% weight loss is not a staggering loss and it might not sway the FDA into putting a drug on the market due to the risk factors associated with such drugs and the risk is greater the more widely the drug is likely to be used. The spokesperson puts the weight of the decision into perspective when she says that when assessing a drug’s potential for market, the FDA is potentially approving a medication to be used by one-third of the population.

A clinical professor of medicine at Cornell University was also present and suggested that focusing on how obesity effects health should be the next step. For example, a lot of people cannot tolerate treatment for sleep aponea but if clinical trials could prove that managing their weight with the aid of weight loss drugs could relieve the sleep apnea, this could be a way of moving forward.

Discussion will continue in this area but the obesity experts were happy to have had the opportunity to engage in such a discussion with the all-powerful FDA. We will be updating the weight loss news page with the latest in pharmaceutical news. For now, Vivus who have presented more data on their weight loss drug, Qnexa, are currently being assessed in the United States in the EU. We will have more news on this later this year.

Very disappointing news for the millions of obese Americans as the FDA rejects weight loss drug Contrave, insisting on an extensive cardiovascular study.

Hopes had been high that the FDA would give Contrave the green light after it got the thumbs up from the endocrinology advisory committee in a 13-7 vote back in December. During clinical trials, small increases in blood pressure and heart rates were observed, both of which ring alarm bells when it comes to cardiovascular safety. It had been suggested by the advisory committee that a post -marketing study would be a sensible way to glean observations relating to cardiovascular safety that might affect the risk/benefit profile of Contrave, which is already pretty close to the threshold that qualifies a weight loss drug for approval.

All of this is very disappointing for Orexigen, the drug company behind Contrave. Although it has $150 million in the bank and another weight loss drug candidate making progress, the bill for an extensive additional clinical trial may be enough to sink Contrave. We expect to hear more from the company in the coming days as its share price takes a battering on the New York Stock Exchange.

Vivus’ shares have dropped since last Wednesday’s meeting with the FDA.  The side effects associated with their weight loss drug, Qnexa, have been a point of worry for the FDA (Food and Drug Administration) and they will have to respond to questions regarding the rate of such side effects.

On the bright side, Vivus will not have to complete further clinical trials. Specifically, the FDA want to know if it is possible to use existing data to find out how frequently women who use one of the drugs ingredients, topiramate for migraine, subsequently give birth to babies with cleft palates.

The drugs company that manufactures this ingredient as Topamax for migraine, warn that birth defects and low birth weights are a risk when the drug is taken by pregnant women. Vivus say that 15% of the women participating in their clinical trials took Qnexa and no birth defects were reported. Vivus will decide whether or not they will be able to carry out this analysis in order to get ready to apply once again for the approval of Qnexa.

Finally, a glimmer of hope for those seeking weight loss pills. Orexigen’s Contrave has been recommended for approval by a panel of the FDA (Food and Drug Administration). The panel voted 13-7 in favour of the weight loss drug. We await the decision of the FDA which is due to be announced on the 31^st January. The agency usually follows the advice of their panels.

Contrave functions to prevent food cravings. Both of the drugs that combine to form Contrave have a history of safety and efficacy and the results look promising.There is more information on this drug’s efficacy and safety on our own Contrave page.

The cardiovascular outcomes study has yet to be evaluated but it is suggested that this is done after the drug has been approved. The panel voted 11-8 that safety studies should be carried out only after this point.

Orexigen’s weight loss drug Contrave, is next up on the chopping block but it might experience more mercy than the recent spurt of weight loss treatments that were refused approval this year. Contrave has proved successful in trials and it is hoped that this will be recognised as effective and safe by the FDA (Food and Drug Administration).

It will be announced on January 31st whether or not the drug will be approved. Until then we will have to analyse the reactions of the panel following the meeting this coming December 3^rd. With Qnexa and Lorcaserin out of the picture for the tine being and since the voluntary withdrawal of Sibutramine from the market, it is not expected that another weight loss drug will make it across the finish line.

The ingredients that make Contrave include bupropion, used in the treating of depression and as a smoking cessation aid and naltrexone (used for alcohol and drug addiction therapy), are both used widely and the efficacy of these drugs is rarely in question. Considering this and the success of the Contrave trials in terms of weight loss, there is still hope.

Cardiovascular related illnesses and side effects have been a hot topic this year regarding weight loss treatment and the bupropion ingredient in Contrave has been known to speed up heart rate and increase blood pressure. Orexigen discussed in reports that blood pressure decreases when weight is lost so the overall effect is beneficial. There was a slight increase of heart rate so this would need to be monitored during treatment.

It is up to the panel for now to sway the decision of the FDA this January. We will report the panel’s feedback as soon as news comes in.

Vivus, the biopharmaceutical company behind investigational drugs Qnexa and Avanafil, has just reported its financial results for the first nine months of 2010. Within those results there is a clear indication that the company has not in any way been floored by the recent decision by the FDA not to approve Qnexa, its investigational weight loss drug that contains low dose phentermine and topiramate, both of which are licensed separately in the US. Vivus says that it will answer the FDA’s questions within 6 weeks. It has already released the extended clinical data requested by the FDA that demonstrates the safety and efficacy of Qnexa over 108 weeks, with patients achieving and maintaining a weight loss of at least 10% of body weight over the period – far in excess of the 2.5% achieved by trial subjects on the placebo.

The FDA’s concerns relating to Qnexa surround the increased heart rate identified in some cases during the trial period. The main concern that needs to be addressed is that the increase in heart rate does not affect overall cardiovascular risk. The FDA is also concerned about potential birth defects caused by the Topiramate element, which has an established risk in this area, albeit at a much higher dose than in Qnexa. 13 women gave birth during the Qnexa clinical trials and none of the babies suffered birth defects. We would expect pregnancy to be included as a contraindication with this drug, just to be on the safe side. There is a possibility that Qnexa will be approved as a controlled drug and will therefore not be available online through legitimate channels.

Vivus has now indicated that it will be applying for a license for Qnexa in the EU before the end of 2010 – this is real news for most of our readers as it is the first time that it has been mentioned explicitly by the company.

Vivus has also stated that it is pushing to complete phase III trials of Avanafil, its investigational medication for the treatment of erectile dysfunction. Avanfil is very similar to established drugs in this area such as Viagra and Cialis but it has a much faster onset time. Patients taking Avanafil were able to achieve erections sufficient for penetration within 15 minutes of oral administration. Given that the medication is very similar to other licensed medications and no major new side effects have been reported, we would expect Avanafil to get a license.

The FDA (Food and Drug Administration) has rejected Qnexa, the third weight loss drug in as many weeks that did not meet the requirements of the FDA.

It has been requested by the FDA that Vivus (Qnexa’s manufacturers) report further on the potential of the drug to cause birth defects and cardiovascular problems and Vivus said that they were confident that they would have this information within 6 weeks. If this goes well for Vivus, Qnexa could be approved next year.

In clinical trials Qnexa was very successful, reporting an average 10.6% loss of their original weight after the first year, contrasting nicely with a weight loss of only 1.7% among those who were taking the placebo.

Orexigen Therapeutics is still set to present their Contrave weight loss to the FDA in December.

Vivus, the California based biopharmaceutical company today announced the results of a two-year study of Qnexa. Qnexa (which has been covered by us many times) comprises phentermine and topiramate and is hoped to be approved as a weight loss medication. Qnexa got the thumbs down by an influential committee of the Food and Drugs Administration in the US a few months ago based on the fact that they only presented data for 1 year.

The results announced today were taken from the SEQUEL study, which was a 52-week study for a specific group of patients who had participated in the CONQUER study prior to this. Altogether, the results comprise 108 weeks of research so this may satisfy the FDA. In the SEQUEL study, patients were given the same treatment that they were given in the CONQUER trial including a top-dose, a mid-dose or a placebo and were asked to reduce their intake of food by 500 calories per day.

Patients taking the high dose of Qnexa were successful in losing weight and were able to maintain the weight loss. An average of 11.4% of their original body weight was reported to have been lost and the loss maintained. No serious side effects or complications were reported other than constipation, tingling in the fingers and toes, dry mouth, altered taste and problems sleeping.

The reports were not just glowing regarding weight loss but the drug contributed to improvements in related ailments and conditions such as high blood pressure and high levels of cholesterol and fats in the blood and diabetes. For those patients without diabetes, the numbers developing the disease dropped significantly, reducing the incidences by 54% at the mid dose and 76% at the top dose.

The SEQUEL study showed that those taking the top-dose of Qnexa experienced a weight loss and maintained this loss for 2 years with a reduction of 11.4% of their original body weight observed. Those taking the mid-dose lost and maintained a loss of 10.4%. Comparing this to the placebo where only a 2.5% weight loss was experienced, the reports are promising.

The majority of patients taking Qnexa lost more than 10% of their original body weight, which is a benchmark that is looked at in terms of additional health benefits derived by formerly obese people. In addition, there was no evidence or report of suicidal attempts, depression rates improved and there was a substantial decrease in the instances of anxiety, cardiac disorders, and sleep disorders in the SEQUEL study compared with the CONQUER study of one year.

Out of 4,323 patients included in the reports of the SEQUEL study, the rates of serious cardiovascular and neurovascular events were similar to the placebo, with a risk of 0.59%.

Following on from our news on Reductil yesterday, we have now heard that the FDA Advisory Panel has recommended against approving Lorcaserin as a weight loss drug in the USA. The vote was 9 – 5 against approval. The FDA does not have to follow the recommendation of the panel but it normally does so.

The Enrocrinologic and Metabolic Advisory Panel members were concerned about tumours in rodents that were used in early stage testing of Lorcaserin. The Panel was also concerned about potential depression and memory loss caused by the experimental drug as well as potential birth defects. Arena, the patent holder and applicant, has countered that the tumours in rats were not applicable to humans as they developed as a result of high dosing and biological process that are specific to rodents. Indeed, there are a number of drugs on the market that have caused tumours in rats but not in humans but clearly more tests are required here.

There was criticism of Arena for not including more subjects in the trials who had diabetes and high blood pressure as these two conditions often accompany obesity so would be likely to be relevant for the population group prescribed the drug in clinical practice.

Arena will now enter discussions with the FDA about a way forward. We know that trials involving patients with diabetes are under way and we should have results on those by the end of the year. Although the weight loss achieved was only 5.8%, this could make a dramatic difference in terms of health outlook for obese patients so we do not think that we have heard the end of Lorcaserin.

We have more news on the drug companies that continually endeavour to find an effective weight loss pill to beat the international problem of obesity. Dr Peter Guzzo of Albany Molecular Research Institute spoke at The 6^th Obesity and Diabetes Drug Development Summit about the commencement of a phase I human trial of ALB-127158, an MCH1 receptor antagonist that may prove to be safer than other experimental drugs in the same classification and bring about weight loss far in excess of anything that we have seen from any other weight management medication.

The new drug affects receptors for MCH (Melanin Concentrating Hormone), which is a naturally occurring peptide that is found in mammals and has an effect on appetite and body weight regulation. It has long been established that the antagonism of the MCH1 receptor in the central nervous system has the effect of reducing appetite and body weight but it has never been achieved without causing major side effects.

Results of preclinical testing of this novel MCH1 receptor antagonist showed a weight loss of 18% after 28 days in obese mice. This weight loss is massive and we would be astonished if this could be repeated safely in humans. The weight loss was observed to be caused entirely by a reduction of food consumption, with an associated preference for the reduction of fat reserves. The weight loss was also observed to be accompanied by an improvement in glucose tolerance.

As far as we are aware, this is the first MCH receptor antagonist deemed safe enough to advance to Phase 1 human trials so this is very exciting indeed. Cardiovascular safety has been established in mice but this may not translate to humans. Also, as we are dealing with receptors expressed primarily in the hypothalamus of the brain, the risk of some form of psychiatric side effects must be quite high but that is not to say that they will be serious enough to deem the drug unsafe – especially if large scale weight loss is repeated in human trials. That being said, even if this drug does make it all the way, it will be years before it will be available to doctors to prescribe.

Rather surprisingly, an FDA panel has voted against approval of the proposed weight –loss drug Qnexa.

The vote, taken yesterday, was narrowly lost by 9 to 7. The panel said that though they believed that Qnexa was effective, they were worried about granting approval before several key safety concerns are resolved.

The panel agreed that the new medication does work better than any currently approved weight loss drug, enabling users to lose up to 14.7% of their body weight when used in conjunction with a diet and exercise program.

However they were concerned that the medication could potentially cause a series of side effects, including birth defects, an increased suicide risk and an increased risk of kidney stones.

Qnexa uses two medications which are already on the market, phentermine and the seizure drug topimirate. While both medications are approved separately, it seems that the panel were disturbed by how many people were projected to want to try the medication. Millions in America are obese and a large number of those are likely to want to try a new slimming pill, were it to be available.

The panel said that as the clinical trials lasted for only a year, it was ‘impossible to extrapolate the trial data to the wider population’, according to panel chair Kenneth Burman of Georgetown University.

While the FDA does usually follow the advice of their panel when deciding whether or not to grant approval for a new medication, they are not obliged to do so. The closeness of the vote made FDA Deputy Director of Endocrine Products, Eric Coleman, say in a news conference that there was a sense that a lot of people were hesitant over whether or not to give the drug the go-ahead.

Scientists are claiming to have discovered a chemical which could stop humans wanting to eat for pleasure.  This, according to the Daily Mail, means that at some point a pill could be developed which could curb those totally illogical but oh-so-delicious cravings for post-pub kebabs, movie-night maltesers and bad-day binges.

Admittedly, scientists have so far only been working with mice, but they say that the chemical hemopressin has been shown to work in a very similar way to the now-banned appetite suppressant rimonabant, or Acomplia, as it was better known.

Hemopressin is produced in rat’s brains and affect blood pressure and pain sensation, as well as the part of the brain associated with appetite, the cannabinoid receptors in the hypothalamus.

The team who conducted the research are from the University of Manchester and the University of Maine.  They used mice who were both a normal weight and genetically engineered to be obese. They were all housed and fed similiarly and then part of the group was injected with hemopressin. Their food intake was then assessed at various points.

The team discovered that both the obese and normal rats responded to the hemopressin with a loss of appetite overnight. Their appetites decreased more when they were given stronger doses. After 12 hours, their appetites returned to normal.

While the research certainly does suggest that hemopressin could have potential as a diet medication, taking drugs from animal trials to approval from regulators can take up to a decade. So dieters waiting for the next big thing will be better off following news on Qnexa, Contrave and Lorcaserin, drugs which have a more realistic chance of being approved soon!

Drug firm Arena Pharmaceuticals have confirmed that they have struck a multi-million pound deal with Japanese firm Eisai Inc to fund the commercialisation of their new slimming medication, Lorcaserin.

Arena is hoping that Lorcaserin could be the first of their products to go on sale and are hopeful that the FDA will grant approval for the medication.  They are expecting the FDA’s panel to review the drug in mid-September and make a final ruling at the end of January 2011.

The company recently revealed the results from late-stage trials into the drug, which saw 47% of those taking the medication lose at least 5% of their body-weight, compared with 23% in those who were given the placebo.

The drug, one of a few expected to go on sale in coming years, works by sending messages to the brain that promote feelings of fullness and satiety, reducing appetite and helping obese patients eat less.

The new deal with the Japanese firm will see Eisai gain the rights to sell Lorcaserin in the U.S, for which they paid $50 million upfront. Arena could also receive large-scale payouts if they gain approval from regulators and further sums dependent on the level of future sales.

Researchers from New Zealand have released a report claiming that Reductil, the recently-banned slimming pill, has a better safety profile that it has been credited with by European regulators.

While the drug is no longer available in the European Union, it is still approved in New Zealand.

The new study followed nearly 15,000 obese or overweight patients who has been prescribed the drug. In their summary, the authors pointed to crucial differences and different results to those obtained from the American Scout study, which lead to the drug’s loss of license.

The lead author of the NZ report, Dr. Harrison-Woolrych, said that the SCOUT study showed that the overall risk of death associated with Reductil was 10 times higher than that which they demonstrated in their study.

There was also a far lower rate of death than that of the American study. Dr. Harrison-Woolrych suggested that the death rate might have been lower as the average age of the participants in the study was lower than those who took part in SCOUT.

The SCOUT study has been criticised as it involved patients with a high risk of heart problems already, though patients with a risk of cardiovascular disease are excluded from being prescribed Reductil.

The study, which has been published in the journal Drug Safety, had been greeted with cautious interest by New Zealand’s own regulators, Medscape. They are currently reviewing Reductil in light of the European ban.

The group manager for the regulators, Dr. Stuart Jessamine, said that the study showed that the drug was safer than indicated by previous studies but said that his organisation would be assessing the totality of the evidence, rather than one study in isolation.

The Online Clinic is pleased to announce that it is now able to supply a new appetite suppressant. Since Reductil had its license suspended in January, we have been looking for something safe and effective to replace this popular and effective treatment.

From today we will be selling Appesat. Appesat is not a medication as it is not absorbed into the bloodstream but it is classified as a Certified Medical Device so it has been through a clinical trial to demonstrate is safety and efficacy.

If you have already had a consultation for losing weight and that consultation has been approved, then Appesat will have been added to your account automatically so you can just login and make a purchase. If you have not yet had a consultation with us, just click on the Free Consultation button to proceed. Your consultation will normally be reviewed within one hour.

A doctor struck off the medical register has now been jailed for illegally selling slimming pills to patients nationwide.

Sudesh Madan, of Romford, Essex, has been given an 18-month jail term by the judge at St. Albans Crown Court. She pleaded guilty to 4 counts of possession with intent to supply a controlled drug and 4 counts of supplying a controlled drug. She also asked that 8 other offences be taken into consideration.

Dr Madan was first arrested in December 2009 by officers from the Serious and Organised Crime Group. They discovered that she had been selling Phentermine and Diethylproprion, both prescription-only drugs not recommended for long-term or medium term use, at branches of Easy Slim clinics nationwide.

It is thought that Madan first started running the clinics after she was struck off the GMC register in 2001. Patients thought they were dealing with a registered doctor as she ran them through a consultation and then sold the pills for about £20 for a week’s supply.

Her fraud was only uncovered when a patient of hers was involved in a traffic accident and revealed to police that she was taking slimming pills prescribed by the ‘doctor’.

Detective Inspector Ian Butler described her as motivated by ‘greed’, and said that through her large-scale operation she could have put patient’s lives at risk. The police are now seeking to seize the profits she accrued through the clinics via the Proceeds of Crime Act.

Newcastle University scientists have said that research indicates that seaweed could be a powerful tool in the fight against obesity.

They have discovered that the fibre found in sea kelp, alginate, can reduce the update of fat by the body by up to 75%.  The scientists created an ‘articifical gut’, which was used as a tool to test how 60 different natural fibres affected the digestion of fat.

Alginate is already used in foods in small quantities as a thickener. Dr. Iain Brownlee, who headed the research, said that their findings suggested that if the seaweed product was added to commonly eaten foods, such as bread, biscuits and yoghurts, three quarters of the fat content in the meal could just pass through the body.

He added that when his team added alginate to bread, initial taste tests were encouraging and that they were agreed clinical trials were now needed to see how effective alginate is when eaten as part of a normal diet.

He added that many slimming pills sold over the counter made claims for miracle weight loss, but only a few had gone through clinical trials to gain scientific evidence to back them up.

One pill already uses alginate as the key ingredient, Goldshield’s APPEsat. Clinical trials showed the pill reduces appetite, though this is thought to be due to the seaweed expanding in the stomach and sending messages to the brain relating to satiety and how full the belly is.

Obesity charity The National Obesity Forum greeted the Newcastle team’s findings cautiously. Dr. David Haslam, chair of the organisation, told the BBC that the findings looked interesting but that they could only recommend it if there were positive results from vigorous trials.

Vivus Pharmaceuticals, who are developing the experimental slimming drug Qnexa, have announced that they have been issued with three new patents for the drug.

The three new patents now mean that the firm has 4 patents for the medication, which is being developed as an investigational new candidate for the treatment of obesity. One provides the company with protection over broad composition of matter, while another provides expanded protection over how Qnexa is used with overweight patients.

The final patent is regarding the dosage of the medication, the formulations for controlled released and how other conditions, such as sleep apnoea, can be treated with the drug.

Clinical trials have shown that as well as treating obesity, Qnexa could also be used to help sufferers of sleep apnoea, a frustrating condition where the nasal passages narrow during sleep, causing sufferers to wake up regularly with a snore. As well as being irritating, it can cause high blood pressure and other health problems.

The president of Vivus, Peter Tam, said that by having the patents granted, the intellectual propretty coverage afforded to Qnexa was considerably expanded and added that they believed the grandint of the patents indicated that the Patents Office recognised the unique aspects of the treatment.

The patents mean that should Qnexa be approved by the regulators, it will be protected until 2020.  

An American man who for 30 years sold diet pills he promised would lead to effortless weight loss has been sentenced to 20 years in prison.

During his career, Frank Sarcona was served with orders from numerous judges across America but continued to pay for lurid adverts in newspapers and magazines claiming the pills would make fat just disappear.

Copy included promised like, “Blast up to 49 pounds off you in only 29 days!” and “Amazing Fat-Fighting Super Pill Devours Fat!” and while thousands desperate to lose weight believed the fabulous claims, they were based on nothing but lies.

Sentencing Sarcona, U.S District Judge said that the number of people taken in by the fraud was ‘astronomical’. District Attorney Kerry Baron described how Sarcona and his partner made over $10,000,000 from 130,000 people between 2000 and 2004. Some people were promised they would be part of a clinical study, while his adverts for the Lipoban Clinic featured a Mexican doctor unliscensed in the U.S.

Mr. Sarcona claims that despite his 62 charges of fraud and the lengthy jail term, he is the victim of the government, who do not share his belief in diet pills, describing himself as a ‘champion’ for dietary supplements.

Investigators previously convicted him for a massive fraud involving pills called ‘Slim America’, where the doctor touted as his spokesperson was actually revealed to be suffering from dementia in a nursing home.

Then, Sarcona was ordered to post a $5m bond, but it was never done. However eventually the millions he made was discovered in a Bahaman bank account and the money was returned to consumers.

We at the Online Clinic think the significant jail term is an excellent step towards cracking down on the criminals who raise hopes and create false beliefs in obese patients when they promise ‘magic’ solutions. No diet pill can melt fat away and with any slimming pill, diet and exercise will always be needed for the pill to work.

A new slimming drug designed to shrink fat tissue has been shown to potentially be more effective than bariatric surgery – though it totally failed to work as the scientists expected.

When the company was founded in 2008, it intended to create drugs that block the formation of blood vessels, a similar technique to that of cancer-fighting medications. They hoped that the process would shrink fat tissue, rather than work on the receptors in the brain like other slimming pills in development.

However, over the past year the company developing the drug, Zafgen, discovered that the mechanism did not work as they thought it would, having no effect on angiogenesis, or the formation of new blood vessels.

Nonetheless, the company discovered that the drug did encourage extreme weight loss and shrinkage of fat tissues in mice and rats. They believe that the effects are so profound they could be comparable to surgery such as gastric banding.

It has been suggested that the drug works by encouraging the cells in an obese person’s fat tissue to release fatty acids into the blood stream, where they are burned up as energy. Another possibility is the byproducts of fatty acids, ketone bodies, can be suppressed due to the high amounts of insulin in an obese person’s blood. The drug seems to unlock the fatty tissue to fatty acids can be released, as well as encouraging the production of ketone bodies, allowing released fat to be burned up.

The company is now launching its first clinical trial in Australia, involving 40 obese women. The main goal is to see if the drug is safe, well tolerated and can be absorbed by the body. The participants will receive injections of the medication twice a week.

If the initial clinical trial is successful then Zafgen will launch larger trials, as well as seek to raise more capital to fund research into the experimental drug.

The recent withdrawals of Acomplia and Reductil have left a big gap in the weight loss drug market. Obese patients might have been left disheartened that pharmaceutical companies might never be able to produce a safe and effective drug to combat the obesity epidemic.

Weight loss drugs it seems, however, are rather like buses: you wait a while for one, then three come along at once. Lorcaserin, Contrave and Qnexa are three weight loss drugs, which have completed the final stages of clinical trials and are now with the Food and Drugs Administration where their safety and efficacy will be assessed.

As we have already reported in The Online Clinic blog, researchers have reported great successes in the clinical trials of Qnexa. The results seem positive too for Lorcaserin, a drug being developed by Arena Pharmaceuticals. Whilst the weight loss reported was not as significant as that for Qnexa (about 5 percent compared with between 8 and 15 per cent for Qnexa) Lorcaserin was also shown to improve fasting glucose levels and blood lipid measures.

With the recent scares over Reductil and Acomplia however, the race is still an open one. The successful drug or drugs, that is to say the ones that get approval from the FDA or the European Medicines Agency, are the ones that are proven to be, in the first instance safe, and in the second, effective.

Arena is hoping that the drug will be able to moderate appetite and prevent excess hunger cravings. Arena hopes that they will be able to put Lorcaserin to commercial use later in 2010.

Officials in New York have announced that they shut down 72 websites illegally selling prescription-only slimming pills.

In the international operation Pangea II, which saw Interpol, U.S agencies and task forces in 2 dozen countries work together, 751 websites were monitored and 72 were shut down. Officials investigated over 16,000 packages of potentially counterfeit medication, leading to a haul of almost 167,000 counterfeit and illegal pills. These included not only diet pills but antibiotics and steroids.

In total, 22 people have been taken into custody to be questioned over the findings of the operation.

There are believed to be many websites operating on the internet which claim to sell genuine Reductil, Xenical and herbal pills, which have actually been stolen or manufactured in illegal factories. Both Reductil and Xenical should only be sold with a legitimate doctor’s prescription.

The investigators said that many of the slimming pills seized where thought to be placebos or contain dangerous levels of the active ingredient used in the genuine forms of the medication. They also warned that counterfeit pills were often cut with dangerous other substances.

Interpol Secretary-General praised the operation, saying that officials have proved that the internet is not an ‘anonymous safe-haven’ for those using it for criminal purposes.

The pharmaceutical firm Vivus have announced that data on their new diet pills Qnexa will be released today at the annual meeting of the European Association for the Study of Diabetes, which will be taking place in Vienna in Austria.

Last month Vivus published very promising phase 3 data taken from their two-year clinical trial. The results showed that Qnexa promoted weight loss, as well as causing patients to experience improvements in their blood sugar, blood pressure and lipid levels.

While the medication is already in stage III trials as a diet pill, Vivus also hope to receive FDA approval to market it as a diabetes medication. Diabetes and obesity are very closely linked and medical experts have warned that as obesity increases worldwide, so too will the numbers of people developing type 2 diabetes.

The data Vivus plan to share with the conference is specific to the diet pill’s potential for combating diabetes. They have already announced that the medication significantly reduces patients haemoglobin, an indicator of blood sugar levels and it is already known that weight loss can improve people’s risk factors for the illness.

The president of Vivus, Leland Wilson, said in a press statement that he believed Qnexa had the potential to play an important role in the treatment of diabetes in the coming years.

The market share price of the pharmaceutical company Vivus has soared after the company published promising results from its late-stage clinical trial into the new diet pill Qnexa.

The medication is a combination of two drugs, the epilepsy medication called topiramate and the weight-loss drug phentermine. This was previously a popular diet pill but fell out of favour with doctors and specialists after effectiveness and safety concerns.

The Phase III trials showed that patients taking the medication lost a significant proportion of their body weight and also showed a reduction in their blood pressure, likelihood of developing type 2 diabetes and fat levels.

The trials were randomised. One involved 1,267 morbidly obese patients and the other involved 2,487 patients who were overweight or obese and had other health problems like diabetes or high blood pressure.

After a year of taking part in the trial, patients taking the medication at the highest dose lost 10.4% of their body weight on one trial and 11% on the other, compared with 1.6% to 1.8% amongst those taking the placebo. After taking into account the placebo effect this added up to weight loss of 9%, well surpassing the 5% the FDA demands for approval for a new diet pill to be approved.

Further FDA benchmarks were met when 70% of patients taking the drug lost at least 5% of their body weight, compared to 20% taking the placebo. The FDA say that at least twice as many patients taking a medication as those taking a placebo must lose at least 5%. However about 40% of those taking the high dose did not complete the year of treatment so this could be significant.

Vivus, based in California, say they plan to ask for FDA approval next year. We are not sure at this stage if the company is going to seek approval in the EU as phentermine has had a problematic history with the European Medicines Agency. 

A Scottish shipping firm has become the centre of an international investigation into the sales of diet pills.  The company they were working with is now being investigated by trading standards in the UK, as well as officials abroad.

Phytoscience, a pharmaceuticals distribution company, started working with Trading Planet Ltd in May. Since that time customers have been complaining in their hoards about an offer that seemed to promise a £1 trial of ‘Life Cleanse’ and ‘Acai Berry’ products. They failed to see in the small print that it contained a clause allowing Trading Planet to continue to send them further batches of the diet pills for £79 if they failed to cancel the agreement within 15 days.

Phytoscience said they have received many complaints from angry customers as their warehouse address was given as the return address. Their director, Chris Swainson, even said he had been sent rude letters to his home after furious consumers tracked him down.

He said that Trading Planet, who are believed to operate from Spain, are one of 12 clients. Phytoscience promised that if the deal was proved to be a scam they would ‘drop them like a hot potato’ but said that if they were working legally, they would continue to work with them.

A rise in the number of doctors prescribing weight-loss drugs in Scotland has dramatically increased the amount the Lothian Primary Health Care trust is spending on tackling obesity. Over two years, there has been a 20% rise in spending meaning that NHS Lothian is now spending £400,000 on slimming pills.

The rise has led councillors to question whether the prescription of slimming drugs is replacing helping patients change their diet and lifestyle. Alison Johnston, councillor, said that they needed to get away from a “culture of a pill for every ill.” She added that the money would be better spent on healthy-living initiatives.

Since 1999, the bill in Lothian for weight loss drugs has risen from £5,000, imitating the same trends seen nationwide. The rise in cost is due to developments in the medical world, which has been racing to produce more effective slimming pills.

At the moment there are two drugs which are prescribed on the NHS, Reductil, which allows the body to feel satisfied with less food, and Xenical, which reduces the amount of dietary fat absorbed by the body. Various companies are currently running clinical trials for new pills, including Orexigen Therapeutics, who recently posted good results from their clinical trials for Contrave.

A consultant at the public health department, Dr. Colwn Jones, said that the trust did offer people support in maintaining a healthy weight, citing diet, exercise and family support as key ways for people to stay trim. He added that medication was a useful help for those people who had made concerted efforts to change their lifestyle but were not successful in losing weight.

Reductil and Xenical are both licensed as last-ditch alternatives that should only be used when someone has not managed to lose weight though diet and exercise alone. Regulators also say that they should be combined with a healthy lifestyle.

Problems have been exposed with over-the-counter sales of the slimming pill Alli after a Which? magazine investigation discovered that it was possible for thin women to persuade pharmacists to sell it to them.

In May the consumer magazine sent 7 undercover mystery shoppers into 32 outlets selling the drug, including popular pharmacy chains like Boots and Lloyds. Problems were noted in 50% of the independant pharmacies and 13% of the chains. Analysing the visits, an academic and pharmacists said they were appalled that 4 times, slim researchers were able to purchase the medication.

Orlistat, the medical name for Alli and its stronger-dose, prescription-only counterpart Xenical, is only meant to be used by people who are clinically obese. Misuse can lead to dangerous side effects, the most well –known of which is flatulence and uncontrollable bowel movements.

However in all cases where the patient was the required weight, key safety questions about the patient’s medical history were asked, excepting one instance in an independant pharmacy. Three times, shoppers were not permitted to buy the slimming pill though they fulfilled the criteria.

The senior researcher who organised the study, Joanna Pearl, said that though they had expected to see excellent results after the training and guidance given to pharmacies about the sales of the drug, it was clear that independant pharmacies were still having problems.

GlaxoSmithKline, who make the medication, said that they believed pharmacists were “ideally placed” to provide customers with weight loss advice and pointed out that they had put an “extensive” training program into place to help them decide whether to make a sale or not. They added that they were committed to providing further training.  

The pharmaceutical company Orexigen Therapeutics Inc today issued a statement saying that late-stage trials of their new weight loss pill Contrave have showed that the medication definitely could help obese people lose weight.

There had previously been questions over whether the pills, previously called Excalia,would meet the standards set by the Federal Food and Drug administration for public sale. However the company say the latest set of trial results exceeded the FDA benchmarks. 48% of patients taking the high dose of Contrave lost at least 5% of their body weight, compared to 16.4% taking the placebo.

The FDA say that there needs to be at least a 5% difference between the weightloss noted in the group taking the medication and the group taking the placebo.

Over a year, the trial saw 3,800 patients take either the medication, a combination of the anti-depressant Wellbutrin and the anti-addiction drug naltrexone, or the placebo. The pills were given at three different levels, the high dose, the medium dose and the low dose. While Orexigen say they will not be continuing the low dose trials as the results were negligible, at a medium dose patients had a mean weight loss of 6.1% of their total body fat compared to the 1.6 loss of the placebo group.

Orexigen say that they plan to file for FDA regulatory approval in the first half of 2010.

A new study has indicated that components in grapefruit may offer hope for the development of a new slimming pill. Researchers have discovered that a flavenoid found in citrus fruit called naringenin may cause the liver to set off a process that burns fat instead of storing it after a meal.

The study showed that flavenoid as well as having potential to fight obesity could also balance insulin and glucose levels, meaning it could be useful in treating diabetes. Flavenoid is known as the ingredient in citrus fruits that gives them there bitter taste and is present in particularly high levels in grapefruits.

The grapefruit diet has long been known to slimmers as a useful way to keep weight down, but the new study has raised it from the ranks of rather faddy diets – such as the infamously smelly cabbage-soup diet – to a rather more credible weight loss tool.

The scientists tested two groups of mice, who were fed the equivalent of a Westernised diet. The diet speed up their metabolic rate, a process known to lead to Type 2 Diabetes, which is dramatically on the rise.

One group of mice was fed food treated with the flavenoid. This group remained healthy, with any cholesterol increases being corrected by the naringenin. The non-naringenin mice became obese and their metabolic rate saw them become insulin-resistant and develop high cholesterol.

The researchers said that the naringenin “completely prevented” obesity in the mice, regardless of calorie intake and without calories being reduced or appetite suppressed. The team is now planning on developing naringenin into a drug that could be taken as a supplement or slimming pill.

Canadian Health Authorities have issued a warning about a supposedly natural slimming product called “Nutural Slim” which has been discovered to be a potential health hazard. Federal officials discovered that the product contained the prescription-only weight loss medication Reductil, though this was undeclared on the product packet.

The product is manufactured by Chinese company Yingtai TCM Pharma Co. and is not licensed for sale in Canada. Health officials warned that no one should take Reductil without a doctor’s prescription and listed the possible side effects, which can include increased blood pressure, chest pain and difficulty sleeping.

There are strict guidelines as to who can take sibutramine, the active ingredient in Reductil. It is not advised for use by pregnant women or by anyone who suffers from depression or psychiatric illness. However, as the makers of Nutural Slim were not disclosing all the ingredients, it is very possible that patients contraindicated for sibutramine inadvertently took the medication, thereby putting their health at risk.

The product has been recalled by the distributor from the market place and health officials have advised retailers to remove Nutural Slim from their shelves and consumers to take back the product to the shop from where they bought it. They have also asked consumers not to buy the product from internet sellers.

Shocking statistics released by the NHS this week have shown that there has been dramatic rise in the numbers of Scots being prescribed slimming medications. Estimates suggest that over 10,000 Scots are taking medications to promote weight loss, with 100,000 prescriptions written in 2008, 6,000 more than the year before. A public health expert from Glasgow University, Professor Michael Lean, has warned that they are being handed out over-enthusiastically and unaccompanied by proper advice.

Lots of newspapers are touting the statistic that prescriptions have risen “25 fold” over the past ten years, but considering that safe diet medications had only just been developed in the nineties, it’s not that surprising that prescriptions rates would rise once they hit the market. Reductil and Xenical, the only two medications authorised by the NHS for prescription, received approval by the National Institute for Clinical Excellence in 2001.

Strangely enough however there has not been an increase in the cost to the taxpayer over the past two years, due to a drop in the price of the medications; between 2006-2007 and 2007-2008 there was a dip of £4.89 million in price. Over the next three years the Scottish Executive is planning to spend £56 million on a variety of initiatives aimed at encouraging the Scottish to exercise and improve their diet.

The figures also showed that over the last year there has been a 23% increase in prescriptions to help people quit smoking, such as Champix and Zyban. The total cost to the taxpayer increased by over £2 million. Scotland, as well as having the highest obesity rates in Europe has the largest number of smokers in the U.K.

The UK’s leading brand protection organisation, Mark Monitor, has just published a report warning about the growing illegal trade in diet pills online. At the moment, the UK market in slimming aids is worth more than £55m. However, the research published by the organisation demonstrates the increasing abuse of slimmers that is taking place on the internet.

MarkMonitor say that there are hundreds of websites that are selling prescription-only slimming drugs with no prescription and no consultation. There are two slimming drugs that are widely prescribed in the UK, Reductil (Sibutramine) and Xenical (orlistat). While these drugs are generally safe, they are prescription only for a reason, as there are various contra-indications such as high blood pressure or medications that can make them dangerous. People buying these drugs online without checking with a doctor are putting their health at risk. The websites are also offering drugs unfit for human consumption

The firm says that currently, they were able to identify over three hundred commercial websites where medication illegal without prescription could be bought. They also discovered 377 websites where large quantities of the drugs could be purchased. Charlie Abrahams, a representitive of Mark Monitor said, "This practice can only be reduced by brand and trademark owners effectively monitoring their online sales channels and ensuring that any non-authentic sites are closed down as soon as possible”.

Here at The Online Clinic, we pride ourselves on the safety measures that we have put in place. For us it is very depressing not only to think of the thousands of people needlessly putting their health at risk, but also that unethical websites are damaging the reputations of legitimate online medical service providers. Hopefully, this report will lead to a major crackdown on illegal providers of prescription only medicines online.

Much has been made of the holistic properties of drinking red wine. It has been advocated that drinking it in moderation can have substantial health benefits. One glass a day has been shown to have positive health benefits which include warding off heart disease, cancer and Alzheimer’s disease. Now scientists have developed a drug which has been inspired by red wine, which they claim would allow people to eat as much junk food as they wanted without putting on any weight. It could also, they claim, have many of the health benefits of exercise and may also prevent diabetes.

The drug, which is a synthetic compound that has been developed in the laboratory, is known as SRT1720. It fools the body into thinking that food is scarce and that it has to burn off fat supplies in order to survive. The ingredient in wine that the drug mimics is called resveratrol. The pharmaceutical company Sirtris has already developed a concentrated form of resveratrol in a pill form.

A key to whether or not this drug will eventually be approved for use in obese patients will be its clinical effectiveness and the side effects that it produces. A few weeks after Acomplia was withdrawn in Europe, the issue of possible side effects is a pressing one. Regulators are not keen to approve drugs whose side effects are seen to outweigh their potential benefits.

In experiments, mice that were given the new drug did not put on any weight even though they were fed fatty, high calorie foods. They were also able to run twice as far as the mice that were not given the drug. The drug triggers a protein called SIRT1 that plays a key role in regulating the body’s supply of energy. This results in the body eating into its fat supplies, even when enough food is being consumed to sustain the body.

It is predicted that the drug is about seven years away from being available on the market, though scientists have warned that a lot of research needs to be done in the meantime, particularly into potential side effects. Watch this space....

The Online Clinic news blog endeavours to bring you all the latest news on developments in weight loss treatments as soon as they occur. It is unusual, however, to have a week where weight loss treatments figure so heavily in the national news headlines. There have been two major weight loss stories this week: Acomplia has had its European license suspended and a new weight loss drug has been announced, one which scientist claim will be ‘twice as effective’ as anything currently available.

There were, until last week, only three drugs that were licensed in this country for use as weight loss treatments. That number has now dropped to two. The European regulatory board has decided that the weight loss benefits to be had from Acomplia were outweighed by the drug’s potential side effects of psychosis, depression and suicidal thoughts. With only two drugs remaining, Xenical and Reductil, there is now a gap in the market for a new weight loss drug and scientists have announced that one is already in development, and is producing results which outweigh any of its predecessors.

Tesofensine targets the part of the brain which controls appetite and makes people feel full sooner than they would without the drug. If tesofensine is taken for six months it produces an average weight loss of one and a half stone. That figure is double the weight loss produced by any of the drugs that are currently licensed.

Scientists at the University of Copenhagen carried out the research and studied how the drug affected 200 men and women. The results were published in the medical journal The Lancet. It is reckoned that the drug will be available in about three years time, though it does have a list of potential side effects that include nausea, diarrhoea, constipation and insomnia. When one compares these with the potential side effects of Acomplia, however, they do not seem particularly serious when weighed up against the potential benefits.

We should point out that tesofensine has yet to undergo the critical phase III clinical trials where it is tested on a much larger group of people. It is not unusual for prospective medications to show a less promise once they enter this phase of development so we would caution against too much celebration at this stage. If tesofensine does prove itself to be safe and effective in phase III trials then you can guarantee that this will be a blockbuster drug considering that adult obesity rates have quadrupled in the last 25 years.

Anti obesity drugs work in one of two ways. There are the drugs that prevent the body from absorbing fat in consumed food, such as Xenical, and those which work directly on the brain, depriving it of achieving a ‘high’ from eating, which is how Acomplia and Reductil work.

A new drug that works on the second principle is currently being developed in the United States. It has already been licensed as a treatment for epilepsy and is now being developed as a treatment for addictions to cocaine and alcohol. It is thought that it will also be a suitable treatment for people wishing to eat less.

The drug is called Vigabatrin and stops the brain’s dopamine reward system, which is the basis for people becoming addicted to drugs, alcohol, cigarettes and food. Acomplia too, as well as proving extremely successful in helping people to lose weight, has also been found to help people quit smoking.

The American researchers said that Vigabatrin had no side effects in rats in the tests they carried out. The rats lost twelve to twenty percent of their body weight having been injected with the drug every day for forty days.

The drug has been available for many years as a treatment for patients suffering from epilepsy but carries a warning that it can cause ‘severe’ visual impairment and should only be prescribed after balancing all the pros and cons of the drug. Dr. Stephen Dewey, who was the lead scientist of the research in the States, however, said that these problems only arose when the drug was taken in much heavier doses than that which would be required for weight loss.

Vigabatrin is currently being tested on humans for cocaine and methamphetamine addiction. There are plans to conduct human trials using the drug to treat alcoholism and binge drinking.

Only yesterday The Online Clinic Blog reported the findings of scientists from the University of Pittsburgh. Based on a study of 200 women, the scientists calculated that in order to lose weight, and to keep the weight off, a woman has to do 55 minutes of moderate exercise per day for five days of the week. For the average British woman this is a major lifestyle commitment and one that many women are unable to make. Perhaps reading this news one might have been left thinking that scientists would do better developing a pill which could be taken daily to help us lose weight and become fitter without the need to do any exercise at all.

Well today the news was announced that scientists have had a breakthrough in developing just such a pill. They have developed two potential pills that could be able to offer the benefits of exercise for those who take it, even if they chose to remain in their armchairs and do no exercise at all. The American medical journal Cell reports that the two drugs, which are labelled AICAR and GW1516, are able to increase muscle and stamina and to burn fat.

Mice, which were given the drugs in the clinical trial, were able to run 44 percent further on the treadmill than the mice that performed the same task without the aid of the medication. The drugs that the mice were given had an effect on a gene that is involved in building and regulating muscle. This genetic alteration in turn led to the development of muscle that was more likely to burn fat.

The lead scientist said that developing a pill suitable for humans could, “if you like exercise”, get you “more bang for your buck.” He also added that, for those who did not, the development of such a pill could have huge benefits especially for a condition such as diabetes. He also added that, as many people struggled to get the recommended amount of daily exercise, it was necessary to develop new ways to counteract this problem.

It could be argued that the development of a drug that mimics the effects of exercise will merely promote a society less prone to physical exertion. Is it the future of exercise or a step too far?

Orexigen Therapeutics has started recruiting for the final phase of the Phase III clinical trials for its lead obesity drug – Contrave.  We have previously written about Contrave on this news channel and you can see further details on this exciting new drug in our obesity archives.  Essentially Contrave combines a slow release form of bupropion and naltrexone.  The combination of these two drugs appears to control the amount of food that a patient consumes and the energy expended by that person.  In earlier clinical trials this was demonstrated to help people lose clinically significant amounts of weight compared with those patients on a placebo.  Orexigen has intimated that it intends to file for approval for this new medicine in 2009.