Qnexa’s Second At-Bat

February 17th, 2012 by MorganDowney Leave a reply »

Interest is rising as Vivus Inc.’s next date with the Food and Drug Administration draws near. The Endorinologic and Metabolic Drug Advisory Committee meeting on February 22, 2012 will reconsider whether to approve Qnexa, which is a combination of phentermine and topiramate. Both drugs are already approved by the FDA and are available as generics.  The FDA has put out their briefing materials, as well as that from Vivus on their website. Endocrinologic and Metabolic Drugs Advisory Committee > Briefing Information for the February 22, 2012 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee

The materials indicate that the Advisory Committee will be debating how to mitigate the exposure by women of childbearing potential to half of the Qnexa compound, topiramate.

Media interest is reflected in a front page story by Andrew Pollack in the New York Times. Diet Treatment, Already in Use, to Get F.D.A. Review – NYTimes.com