As we correctly predicted, Lorcaserin has won the vote of the Food and Drug Administration’s (FDA) advisory committee. Since the FDA usually goes with the advice of its panel and considering the vote swung in favour of the drug by 18-4 with one abstention, it looks likely that the approval will go ahead. Lorcaserin will be marketed as Lorqess.

It was said that Lorcaserin’s benefits outweighed the risks and the committee was happy with what it heard in relation to previous anxieties regarding heart valve damage and tumours in rats.

We expect to hear back from the FDA this June and we also anticipate that the European Medicines Agency will approve the drug by the end of 2012, following what we expect to be an approval in the States. EMA accepted the drug’s marketing authorisation application in March this year.

The drug will be manufactured by Arena pharmaceuticals in a plant in Switzerland and distributed and marketed by Eisai. We are keen to start prescribing this medication given the burgeoning problem of obesity and the paucity of options available to patients for whom diet and exercise simply do not work.

There is much buzz surrounding Lorcaserin in advance of 10^th May, the day that the members of a key advisory panel to the Food and Drug Administration (FDA) in the USA voice their opinions on the new weight loss drug. The trade name of Lorcaserin will be Lorqess. The FDA often goes with the decision of its advisory committee but is not obliged to do so, so tomorrow will be an important day for Arena Pharmaceuticals, the pharmaceutical company behind Lorcaserin; especially as this will be the second time they will have stood before the committee attempting to get approval for this drug.

The main focus will be on the pharmaceutical company addressing the safety issues outlined by the committee the last time that Lorcaserin was considered. The concerns included fears over tumours found in rats and the potential for heart valve damage.

We are not too worried about speculation surrounding tumours that were found in rats considering the benign tumours were found in rats during clinical trials and not in humans. The benign tumours are known as fibroadenomas and among rats, are in fact very common anyway whether or not Lorcaserin is administered. Fears over the growth of tumours in humans are unnecessary and are not backed up by clinical trial evidence. We think it highly unlikely that Lorcaserin will stubble over this issue.

The risk of valvulopathy (heart valve damage) was another cause for concern. Years ago, the association between this condition and the weight loss drug fenfluramine, was the reason that the drug was taken off the market in 1997. The FDA is naturally wary, as Lorcaserin comes from the same family of molecules as Fenfluramine. The pharmaceutical company was required to carry out periodic heart scans on the patients during clinical trials to demonstrate that valvulopathy was not a concern.

The company did not observe any increase in the incidence of valvulopathy during clinical trials although the observed levels in the study population was 1.7% against a population incidence of around 2.5%. This may have an impact on the ability to meet the benchmark set by the FDA but the key observation must be the zero increase in incidences.

Possibly of greater concern will be the overall efficacy of Lorcaserin. Although it does meet the FDA’s own benchmark for weight loss drugs, the weight loss is not spectacular overall. However, some patients are high responders and the low responders can be identified at 30 days so treatment can be ceased if the response is lower than would be considered acceptable on a risk benefit analysis.

We have a feeling that Lorcaserin might just make the cut this time although we do not think that it is a sure fire winner because of the low overall response rate.

Arena, the pharmaceutical company responsible for weight loss drug hopeful, Lorcaserin, might yet be the first weight loss drug treatment to be approved by the Food and Drug Administration (FDA) since Orlistat was licensed as the agency has delayed proceedings with the approval of Qnexa for three months. But will Arena have done enough to convince the FDA that Lorcaserin is safe enough to put on the market?

The pharmaceutical company is hoping that the agency will approve Lorcaserin, which will be marketed as Lorqess, despite the meagre 3% difference in weight loss reported between it and the weight loss reported among the placebo control group in phase III clinical trials. However, Lorcaserin did reach the minimum weight loss requirements in that participants lost 5% or more of their original body weights in year one.

It is said that the new drug application submitted by Arena included an explanation regarding the drug and tumours found in rats that had been administered with the drug during animal trials. So, if the panel and the FDA are happy with what the pharmaceutical company has produced in the way of disproving previous concerns regarding the drug’s potential side effects, then the agency may let this one through. We have not seen the details of the explanation relating to the tumours identified in rats but this would not be the first medication that had this effect on rodents but not on humans – we are diffident species after all!

An advisory panel meeting will take place on May 10^th and we are set to hear about whether or not the drug is approved on June 27th. We will update after the advisory panel has reported next week.

The Food and Drug Administration in the States has approved Avanafil for market and it will be branded as Stendra .The drug is expected to join the 4 billion dollar global erectile dysfunction treatment market by 2013 after the drug manufacturers have made decisions regarding the packaging and distribution of the drug.

As we have explained before, Stendra will have an advantage over its competitors in that it begins to work within 30 minutes and has been reported to work after only 15 minutes in some patients. Other PDE5 inhibitors are known to take around 1 hour to get working in certain cases.

The pharmaceutical company also applied to the European Medicines Agency (EMA) on March 26^th of this year and a Marketing Authorization Application was accepted by the European regulators. We will update our pages with the latest news on the approval of Avanafil in Europe as soon as we have it but we expect Avanafil to be approved in the EU before the end of 2012.

We are sorry to say that we are now out of Xenical (orlistat) stock again. We are trying to find some more in the supply chain but so far we have not been successful. We are not taking any more orders at the current time. If you would like to register with us then we can e-mail you as soon as stock becomes available.

We will find out if Avanafil has been approved by the FDA as a treatment for erectile dysfunction after 29^th April. An application has already been submitted in the European Medicine Agency but it is the Food and Drug Administration (FDA) in the US that will be first to make a decision.

Avanafil has a much faster onset than any of the current PDE5 medications on the market and is said to kick in within 15 minutes of administration. There is no doubt that it will have a place on the market but it is going to be difficult to overtake Viagra and Cialis. With Sildenafil (the active ingredient in Viagra) coming off patent next year, Avanafil may also struggle on price – we shall see. We have no doubt that Avanafil will be approved; it is just a question of how large a market share it will be able to develop.

The Food and Drug Administration (FDA) in the USA has now ordered that packets of Propecia be accompanied by health warnings regarding problems with ejaculation, orgasm and libido that are said to occur even after patients stop taking the hair loss treatment.

Propecia already carries a warning on its label regarding a decrease in libido but now the other warnings will also be added to it. Along with sexual side effects, the label warnings will include side effects such as a decrease in semen quality and infertility however these are two side effects that are said to disappear once treatment ceases.

Despite this move, no evidence is available to establish a direct link between Finasteride, the active ingredient in Propecia and Proscar, with these symptoms. The cases investigated have been reported voluntarily and the number of actual reports was very small given the prescribed population, thus making it difficult to draw any reliable conclusions or establish any causal link between the drug and these symptoms.

Drug companies are obliged to advertise such warnings since cases have been reported. However, we assure patients that there is no concrete evidence to prove that Finasteride has these effects on patients and very few of our patients report any side effects whatsoever so Propecia appears to be well tolerated on the whole and we are not aware of any label changes in the UK.

It was often said that anything , Sofia Vergara, Columbian actress from the hit US comedy drama, Modern Family, would say would sound sexy and so she put this statement to the test during her hosting debut on Saturday Night Live by opening with her since much quoted intro, ‘Gonorrhoea, Rick Santorum, and New Jersey’. We don’t think she quite pulled it off this time but speaking of gonorrhoea and sexiness, it did bring to our minds a recent (and not so sexy effort) to highlight the importance of safe sex among the older generations which was prompted by a 71% increase in STIs among senior citizens in Florida over just the last 5 years.

The most recent campaign produced by the DDB advertising agency, depicts elderly couples performing sexual positions based on the teachings of the karma sutra and is being watched by thousands in its video form across the net. The smiling faces of these senior citizens enjoying intimate and ‘tantricly’ challenging moments are set to raise awareness for safe sex among this age group and also to highlight the fact that men and women among the older generations should be enjoying their sex lives regardless of their age.

Some feel that despite the primary objectives of the campaign, the images in fact negate its very purpose, painting a picture of elderly people and sexual activity in a mocking light.

We think the campaign has at least grabbed the attention of the masses and raised awareness in the area of safe sex and the elderly so long may the videos go viral and hopefully keep the over 50s virus (and bacteria) free!

Yet another frightening new diet has been unleashed on desperate brides to be in the USA: the gruesome K-E diet. 800 calories worth of liquid is pumped via a tube through the nose into the blushing bride’s shrinking stomach so that before her big day, she will stand the chance of losing a whopping 10-20 pounds. Forget Martine McCutcheon and her 4 month plan to get into a healthy sized wedding dress before the day approaches; this is the ultimate quick fix with a 10 day guarantee but comes at a price - $1500.00.

Certain doctors in the States sing its praises, stating that it is designed to burn fat rather than muscle and the feeling of hunger will be absent for the entire 10 day period. Others say that the nasal tube is merely a gimmick and that restricting the diet to 800 calories will cause drastic weight loss in anyone who is used to more than the recommended amount.  The diet is rich in protein and contains no carbohydrates, hence the fat burning results (the body will normally convert sugars into energy rather than fat as this is an easier process.)

One of the side effects of this extreme diet is foul smelling breath so the bride might be well advised to stay away from the groom for the duration of the diet, otherwise her big day might be cancelled.