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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.

It has not been a good few years for anti obesity drugs. Acomplia (Rimonabant) was withdrawn from the market in October 2008 and in January 2010 Reductil (Sibutramine) had its marketing authorization suspended across the whole of the EU following the publication of some data that suggested that the drug could increase the risk of non-fatal cardiovascular events in patients with a pre-existing heart condition.

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.

The American Food and Drink Administration has announced plans to monitor more carefully usage of the anti-obesity medication Alli, the lower-strenth version of the prescription-only medication Xenical.

The body has received reports that orlistat may have been causing rare cases of hepatitis and other abnormalities related to the liver. The FDA have said that while they have not decided whether stricter regulation of Alli usage is needed, they will be watching out for any further reports.

When Alli was introduced, some critics said that they were worried that there would not be the same doctor’s monitoring as would be received by a patient taking Xenical. In an edition of the medical journal The Lancet, experts expressed fears that over-the-counter purchase of orlistat might lead people to perceive obesity as something that could be cured just by popping pills.

Since Alli was launched in April, regulators at the MHRA have received reports that 31 people experienced adverse side-effects from taking the pills, Some reports have suggested that pharmacists are not checking carefully enough that patients buying the slimming pills are sufficiently overweight to merit medical intervention.

It is believed that regulators will follow the lead of the FDA should they decide to introduce more stringent regulations. Roche, the manufacturers of orlistat, have denied there is a link between the drug and liver toxicity.

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”.

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 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.

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.

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.

Switch on your television and watch a programme like Fat Club or The Biggest Loser and you might get the impression that losing weight was entertaining or a game. For those who are struggling without any support nothing could be further from the truth. The desire to lose weight can, for many, become so overwhelming that they fall into deep depressions and become too ashamed to leave their own homes.

We have a bit more news on Taranbant - the drug similar to Acomplia that is being developed by Merck.  We have been bringing our readers news on this medication on a regular basis and we thought that you might be interested in an article in the January issue of Cell Metabolism, which discusses the effectiveness of Taranabant at low doses over a 12 week period.

Taranabany works as a CB1 receptor inverse agonist whereas Acomplia is a CB1 receptor antagonist so they work in slightly different ways.  Taranabant appears to cause significant weight loss at doses which block just 30% of cannabinoid receptors in the brain.  Apparently the drug was effective at low doses of 0.5 mg to 6.0 mg.  This compares to a standard dose of 20 mg for Acomplia.

In a double blind trial involving 12 mg daily dose of Taranabant and a placebo, the Taranabant patients were observed to consume 27% fewer calories than those taking the placebo.  It was also observed the the Taranabant patients burned more fat and expended more energy while at rest.  This is a really exciting new drug and we hear that Merck will be applying to the FDA in the US by the end of this year.  It is not clear if they will be making a simultaneous application the the European Medicines Agency but this would make sense.  we have heard that they will not be making a simultaneous application but this has not been confirmed by the company.  As always, we will bring you more news when we receive it!

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.

We have just seen the results of a study from a Canadian research team which suggests that the results that patients get from taking anti-obesity medications can sometimes be disappointing.  Whilst the research showed that there was a greater chance of achieving the weight loss required to get to a healthy body mass amongst people who take the medications than with those who do not, the results were quite often not that impressive.  A number of patients dropped out of the programme early on, which is something that we notice with some of our patients.  This non-adherence by patients is one of the major causes of disappointing weight loss results.  If participants do not follow instructions, it is hardly surprising that they do not lose weight!

The study looked at sibutramine, orlistat and Rimonabant – The Online Clinic routinely prescribes all of these medications.  We find that the results are very much mixed.  Some patients have amazing results whereas some drop out after the first month either because of cost or low levels of weight loss.  Unless there have been side effects, we would normally recommend continuing for three months to see if a 5% weight reduction could be achieved in that time frame.  Normally, with some persistence and a bit of effort on the exercise front, this result can be achieved by most patients.

The study found that those people taking the medications did get other results which have an overall positive impact on their health.  Xenical appeared to have an impact on reducing the incidence of diabetes and all the medications, including Reductil and Acomplia, had an impact in reducing certain cholesterol levels.

Scientists at Tel Aviv University have been working on a compound that really could be a “wonder weight loss drug.”  The drug is known as Histalean and is based on Betahistine, a drug that we have been prescribing for around 30 years to treat vertigo and meniere’s syndrome.  Betahistine is believed to block the H1 and H3 receptors in the brain.  These receptors are connected to a sense of fullness and a desire to eat fatty foods.

The results of a twelve week trial have demonstrated that those on the Histalean slimming pill lost 7 times more weight than those on the placebo.  What is more, no significant side effects were picked up and we know from experience that Betahistine has a very good safety profile.  Currently all of the centrally acting weight loss drugs can have very serious side effects which make them unsuitable for a number of people. 

It would appear that Histalean works better for women rather than for men and it also seemed to work better for those who are 50 or under.

This drug is not available to prescribe for weight loss at the moment but as soon as we have some news on this, we will publish it here.  The recent trial was only Phase II so it has a way to go before the authorities will give it a license for this purpose.

We have written before about the melanocortin system which is part of our central nervous system and has been demonstrated to regulate food intake.  A new study by scientists at the University of Cincinnati suggests that this melanocortin system can also act as a remote control from the brain, giving instructions as to the metabolism and storage of fat around the body.

Tests on rodents have demonstrated that when the system is activated (either genetically or pharmacologically), fat is metabolised.  When the system is deactivated, there is an increase in fat accumulation.

This discovery could be a breakthrough in developing a new generation of slimming pills which targets the melanocortin system as a means by which weight can be controlled.  The research is still in the early stages but studies of humans with a genetic variation in the melanocortin system which causes an accumulation of fat seems to confirm the observations made in the experiments on the rodents in the experiments.

Scientists at Pennsylvania State University College of Medicine have just published a paper which has revealed some very interesting facts that could potentially lead to a ground-breaking treatment for obesity.  The research team carried out experiments on mice by disrupting an enzyme which is involved in the metabolism of amino acids.  This led to continuous cycle of protein synthesis and breakdown, which is believed to have been caused by the elevated blood levels of an amino acid called leucine.

The mice which lacked the enzyme BCATm saw a ten fold rise in blood leucine.  As a result of the enzyme deficiency, the mice ate more food than normal mice but were slimmer.  This was deduced to have been caused by the energy drain caused by the protein turnover.

It would not be possible to get this effect simply by introducing dietary leucine as this stimulates protein synthesis but disrupts the breakdown.  Any solution for humans would have to be via a pharmacological product which would be able to manipulate the activity of the BCATm enzyme.  This truly would be the wonder pill that dieters have been looking for as it would mean that they could eat to their heart’s content and burn off all the energy through an increased metabolism.  Any potential solution in this field is decades away however!

GW Pharmaceutical of the UK, which is fast becoming the world leader in research into the therapeutic benefits of cannabis, has announced that it is to begin Phase I trials of a new weight loss drug which is derived from cannabis.  Cannabis contains tetrahydrocannabinol (THC) which activates the CB1 and CB2 receptors to boost appetite.  However, another substance known as tetrahydrocannabivarin (THCV) is also present and this has the opposite effect.  If the THCV is isolated, this can be used as the basis for a medication which may be able to switch off the appetite. Clearly, this may have serious undesirable side effects so the drug will have to go through years of thorough tests before it is available to prescribe.  As soon as we have some more information, we will post it here.

Scientists have developed a new slimming pill that appears to trick the body into burning fat in a similar way as happens when we exercise.  The drug is many years away from being available to prescribe but it has successfully been tested on mice.  If the drug is confirmed as being safe enough to be tested on humans, it could herald a radical way to treat overweight and obese people.  At the moment, the only medications available to prescribe for patients who are overweight are either lipase inhibitors, which partially prevent the absorption of fats by the body, or drugs which influence appetite by a variety of means.

The drug has been developed by Dr Ronald Evans who has spent many years studying obesity, its causes and its consequences.  The active ingredient in the drug is a synthetic form of fat which appears to work by flicking a master switch within the cells which regulates the laying down or burning of fat.

Previous studies by Dr Evans have focussed on genetic engineering to create a strain of mice that is entirely resistant to weight gain and has a physical endurance twice that of ordinary mice.  As the genetic engineering of the mice had to take place pre-birth, there was no prospect of this having any direct human application as such genetic modification would not be acceptable.  This new discovery, which involves chemical metabolic engineering, is a very exiting development which could eventually revolutionise the lives of millions of people by reducing fatty tissue, lowering blood lipid levels, cutting blood glucose levels and reducing resistance to insulin, thus limiting the risks of heart disease and diabetes.

The US drug development company, Orexigen, has recently announced successful Phase II results for the trial of Excalia, its new weight loss medication. Patients treated over a 48 week period managed to lose an average of 12 per cent. of their body weight. The medication, which may not be available to be prescribed for around 4 years, uses two currently approved medications to target a specific reciprocally paired group of hypothalamic neurons to trick the hypothalamus (the area of the brain which regulates appetite, energy output and body weight) into keeping the metabolism running fast at the point where the body would normally make a compensatory adjustment for the effects of a reduction in body weight.

The medication contains Bupropion and Zonasimide, two currently approved medications used for the purposes of facilitating smoking cessation and the treatment of epilepsy. By using these two different drugs, Excalia offsets the body’s natural compensatory pathways and appears to help slimmers avoid hitting the weight loss plateau that they normally reach a few weeks into their new diet and exercise regime.

The results were recently announced at a conference organised by the North American Association for the Study of Obesity. The company behind the drug is now recruiting patients for a larger scale clinical trial prior to filing for approval with the various drug licensing authorities around the world.