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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.





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