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by Robert MacKay, Thursday, 24 October 2013 | Categories: Slimming Pills

A couple of months ago we reported that Orexigen would be submitting an application for a marketing authorisation to the European Medicines Agency for Contrave, its obesity medication. That submission has now happened and the EMA will be accepting interim results from the company’s cardiovascular outcomes study currently being conducted and known as the Light Study. The concerns about cardiovascular risk are not immediately obvious but this study was requested by the FDA as pre-condition for approval in the US.

Contrave contains two active ingredients that are already licensed individually to treat addictions and depression. The combination of the two work to inhibit appetite. The weight loss achieved in clinical trials was not overly impressive but it did meet the minimum standards required of weight loss medications; the only question was the safety of the medication.

In other weight loss news, the patent-holder of Qsiva has requested information from the European Medicines Agency regarding the scientific data they will require from the cardiovascular outcomes study being conducted in the post-marketing environment in the US where Qsiva is being marketed as Qsymia.  It is our understanding that the scientific advisory committee of the EMA recommended approval of Qsiva but the EMA committee went against this recommendation. One of the objections was that the medication may end up being taken by the wrong people, which is quite frankly a preposterous position to take. All medications could potentially be taken by people for whom they are not intended – that is why we have a system of practitioner prescribing.

Based on the studies we have seen, it is our view that Qsiva is the more effective medication but it remains to be seen whether or not its safety profile established in clinical trials will be borne out in the post-marketing environment.

by Robert MacKay, Tuesday, 27 August 2013 | Categories: Slimming Pills

We wrote on this blog a few months ago about the risks associated with Dinitrophenol and warned the public of the dangers of products contain this chemical. Finally, the UK Government is on the case and doctors have been officially alerted to the dangers of Dinitrophenol (DNP), which is an industrial chemical not fit for human consumption. Along with other medical practices, we have received a notification from the Department of Health to advise patients taking this chemical to stop immediately.

DNP is taken by people who wish to lose weight or just reduce body fat (such as bodybuilders). The chemical has been responsible for 24 UK reported toxicity cases, 5 of which had a fatal outcome. Side effects are varied but include nausea; vomiting; rapid respiration; rapid or irregular heartbeat. Coma and death are also recorded side effects. Longer term use can produce neurotoxic symptoms along with cataracts and unsightly skin lesions.

The toxic effects can be seen at manufacturers’ recommended doses. Our view is that there is no safe dose and anyone tempted to try DNP should think about it for a second: this is all it will take to realise that you are about to embark on a crazy course of action.

You can read more about the latest warning here.

by Robert MacKay, Thursday, 08 August 2013 | Categories: Slimming Pills

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.

by Robert MacKay, Thursday, 25 October 2012 | Categories: Slimming Pills

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 87th 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.

by Robert MacKay, Tuesday, 22 May 2012 | Categories: Diet Pills | Slimming Pills | Weight Loss

We quite often get requests to prescribe Tenuate Dospan for weight loss. We will absolutely never do this but we thought that it might be worth our while doing a blog on the reasons why this medication should not be prescribed.

Tenuate Dospan (diethylpropion) is an unlicensed appetite suppressant that works similarly to an amphetamine, working directly on the central nervous system and affecting the heart rate and blood pressure levels. It is regarded as an unsafe substance by most healthcare professionals but is still being prescribed by a few rogue doctors at unlicensed slimming clinics.

The drug was previously licensed in the UK but the European Commission took a decision to withdraw this license in 2000. Due to the objections of the license holders, the licenses were reinstated that same year only to be taken away once again.

In 2002, the European Court invalidated the decision of the European Commission to withdraw the licenses for Tenuate Dospan. Although the drug is not banned, its use is frowned upon by most in the medical profession, given the addictive nature of the substance and the potential for long term cardiovascular side effects.

We do not deny that there is a yawning gap in the market for safe weight loss medications but it is really not worth putting your health at risk even further by consuming a medication that could hasten the sort of long term consequences of carrying too much weight anyway.

There is one exciting new weight loss medication that could be licensed very soon – Qnexa. This medication has shown huge promise in clinical trials and we believe that it will be a blockbuster medication if it is ultimately licensed.

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