Qnexa’s Second Advisory Committee Review: Smaller Indication, Still Big Safety Questions

23 Dec 2011

• By Martin Berman-Gorvine

Vivus’ weight loss drug Qnexa (phentermine/topiramate) will go before the Endocrinologic and Metabolic Drugs Advisory Committee again on Feb. 22 for an indication that excludes women of childbearing age. And despite additional safety data, cardiovascular concerns look to remain a major issue for the resubmitted application.

While proposing contraindicating its weight-loss drug Qnexa (phentermine/topiramate) for women of childbearing age may remove one major safety concern for Vivus Inc. as it prepares for a secondary advisory committee meeting following a “complete response” letter from FDA, Vivus still faces major cardiovascular and other safety concerns.

On Feb. 22, the Endocrinologic and Metabolic Drugs Advisory Committee will review the proposed indication of the drug as an...