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Qnexa July 2012

FDA Approval of Qnexa is Delayed 

The new weight loss drug called Qnexa (phentermine/topiramate) has already made history by following one of the longest and strangest paths towards approval of any prescription drug in US history.  The drug was announced in the late 2000s and then unceremoniously ‘disapproved’ by an FDA advisory panel in 2010. Traditionally such a “thumbs down” vote from a government panel meant the end of the line for a potential new prescription drug. In the case of Qnexa however its manufacturer, Vivus Inc, regrouped, spent a lot more money pursuing further clinical trials with Qnexa and filed again for approval with FDA. And so in February of this year, a second advisory panel to FDA met in Washington to consider Qnexa one more time and much to the surprise of observers, this second panel voted overwhelmingly to recommend for approval of Qnexa. Vivus’ stock doubled overnight and within a week, it seemed that Qnexa’s final formal approval would occur in April. Instead, the FDA announced that it would delay its decision on Qnexa by three months to July 2012.

And this is where matters stand today. Does the FDA’s delay auger poorly for Qnexa?  Is it a sign that the giant government agency will not follow the advice of its second advisory panel or is the delay a mere formality?  Personally, I think it’s 50/50.