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by Robert MacKay, Sunday, June 16, 2013 | Categories: Lorcaserin

At the beginning of last month we announced that the new weight loss pill named Belviq©, from Arena Pharmaceuticals, was going to be able to be prescribed soon to obese and overweight patients in the United States. Since then, many criticisms have accompanied its debut. One in particular was made by Consumer Reports.

The article gives two main reasons as to why Consumer Reports do not recommend taking the pill. First of all, they claim that studies show that patients who take it for a year are expected to lose only a slight percentage of their body weight (from 3 to 3.7%). Second, the side effects might be quite severe.

Another article, published in the Los Angeles Times, also heavily criticises the drug, saying that patients who decide to take it must take it for their whole life in order to keep the weight off. They also mention that long-term side effects are not predictable and that quick-fix pills are simply not effective at resolving a complex problem such as obesity.

While some of the criticisms may be valid, it is really up the doctor and patient to decide what is appropriate. It is true that some patients do not lose very much weight – this is the case with other weight loss medications as well. The low responders (as we call them) can usually be identified early (within a couple of months) and they should probably stop being prescribed further courses as the risk of side effects may outweigh any potential benefit from the marginal weight loss.

We have to concede that the average weight loss is not impressive and it probably should only continue being prescribed on a patient by patient basis if they are losing reasonable levels of weight. 3% over the course of 12 months is really not sufficient to justify continuing prescribing.

Belviq contains Lorcaserin as the active ingredient. The application for a license to have Lorcaserin prescribed in the EU was recently withdrawn as Arena Pharmaceuticals was not going to be in a position to answer all of the outstanding questions with the European Medicines Agency. We would expect a further application to be made in due course.

by Robert MacKay, Monday, May 13, 2013 | Categories: Lorcaserin

Lorcaserin, the new weight loss drug that has been approved by the US Food and Drug Administration (FDA) and recently categorised by the Drug Enforcement Administration (DEA) under the name of Belviq©, is not likely to be sold in Europe any time soon. This is due to the fact that Arena Pharmaceuticals has decided to withdraw the application made to the European Medicines Agency (EMA). The EMA seemed in fact reluctant to introduce the new weight loss pill in Europe and had recently asked for further detailed product information from the company, extending the process necessary to place the medication onto the European market. Clearly Arena was expecting a negative opinion and decided that a dignified withdrawal was preferable. This is very disappointing, given that lorcaserin is expected to soon be sold in the United States and has been thoroughly tested in clinical trials. However, the EMA has had a history of being reluctant to accept applications to market new weight loss medications. That was the case for Qsiva, Vivus’ obesity pill rejected in the last few months. Further information on this will be reported in due course. In the meantime, we await Swissmedic’s decision, Switzerland’s Agency for Therapeutic Products, which is expected in the summer.

by Robert MacKay, Thursday, May 9, 2013 | Categories: Lorcaserin

The new weight loss drug Belviq© just got a step closer to being available to prescribe in the US. The medication had been approved by the US Food and Drug Administration (FDA) last June: however, Arena Pharmaceuticals was waiting for the Drug Enforcement Administration (DEA) to classify Belviq. Finally, yesterday the drug has been classified as a schedule IV drug (i.e. with low prospective of abuse).

The sale of this medication is therefore scheduled to begin 30 days after publication in the Federal Register, which happened yesterday (8 May 2013).

This medication will be available to overweight and obese individuals to help reduce the body weight, along with a healthy and correct nutrition. The active ingredient of this medication is lorcaserin. The details of how the medication works are still unknown: however what it is known is that the substance activates selectively certain serotonin 2C brain receptors and therefore changes the perception of satiation of the patient. Therefore the individual feels full faster. Side effects of the drug include fatigue, somnolence, impairment of memory and confusion. Therefore patients should be monitored by a doctor especially when starting the first cycle of medication.

We want to highlight that this medication has just been approved in the United States and not in Europe. An application has been filed in the EU but no decision has yet been made.

by Robert MacKay, Thursday, June 28, 2012 | Categories: Lorcaserin | Qnexa | Qsiva

There was some very good (if not unexpected) news from the US overnight: the FDA has approved Lorcaserin as a weight loss pill. Lorcaserin is going to be marketed in the US as Belviq, although we believe that it will be marketed as Lorqess in Europe (if it gets a license here).

Lorcaserin should not be seen as a magic bullet in the sorry tale of rising obesity levels but it will definitely help. Most patients lost at least 5% of their bodyweight over a year and a further third lost at least 10%. Even these modest levels of weight loss with Lorcaserin can bring big health gains, such as reduced blood pressure, reduced cholesterol levels and a greater control over blood sugars, thereby preventing or delaying the onset of Type 2 diabetes.

It is the view of The Online Clinic that this decision augers well for Qnexa, the next weight loss medication up for review. We predict that Qnexa will be licensed in the US in the next few weeks and that a license will be granted in the EU in the autumn.

Please note that neither Lorcaserin nor Qnexa is available to prescribe at the current time. We expect a launch towards the end of 2012 or early 2013. We will keep readers posted and patients who have registered an interest will be e-mailed when these medications become available to prescribe.

by Robert MacKay, Friday, May 11, 2012 | Categories: Lorcaserin

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.

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