Vivus, Qnexa, and re-arranging the deck chairs?

Vivus announced today the preliminary results of a retrospective database review on topiramate exposure during pregnancy.  In short, it potentially links topiramate exposure during pregnancy to an increased risk of oral clefts.  Consequently, Vivus has stock has dropped 17%.

So what does this mean for Qnexa?  We knew there would be a REMS program, but does this increase the REMS requirements?  Will the FDA not approve Qnexa for use in women of child-bearing age?  Does this call for a closed distribution approach?  Will the FDA demand a “named patient” program?  Or program that requires only “approved physicians” to prescribe Qnexa?  Most importantly, even if Vivus produced the most advanced risk mitigation program ever, will the FDA take enough  of a chance to approve Qnexa?  Or is the risk of just one oral cleft offset any chance for approval?

As this is a time of reflection, I have some compassion for the FDA with respect to obesity agents.  They are under political pressures to approve something, but the agents in front of them, are not great advances and have considerable safety concerns.  Where does this leave the FDA?  And where does this leave industry in a search for obesity treatments?

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