VIVUS, Inc. said that the Endocrinologic and Metabolic Drugs Advisory Committee of the US Food and Drug Administration (FDA) is scheduled to review the company's New Drug Application (NDA) for Qnexa for the treatment of obesity on February 22, 2012. VIVUS resubmitted the NDA on October 17, 2011 seeking approval to market Qnexa in the United States. The FDA accepted the NDA for review on November 3, 2011. The target date for the FDA to complete its review of the Qnexa NDA is April 17, 2012.

Qnexa [kyoo-nek-suh] is an investigational drug candidate being developed to address weight loss, type 2 diabetes and obstructive sleep apnea. Qnexa is a once-a-day, proprietary, oral, controlled-release formulation of low-dose phentermine and topiramate, which is designed to decrease appetite and increase satiety (the sense of feeling full), the two main mechanisms that impact eating behaviour. In phase II and III clinical data to date, patients taking Qnexa have demonstrated statistically significant weight loss, glycemic control, and improvement in cardiovascular risk factors, when used in combination with a diet and lifestyle modification programme.

VIVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health.