FDA To Discuss Obesity Drug Qnexa

This morning, the US FDA Endocrinologic and Metabolic Drugs Advisory Committee will discuss the safety and efficacy of new drug application (NDA) 22-580, proposed trade name QNEXA (phentermine/topiramate) Controlled-Release Capsules, manufactured by VIVUS, Inc., as an adjunct to diet and exercise for weight management in patients with a body mass index (BMI) equal to or greater than 30 kilograms (kg) per square meter or a BMI equal to or greater than 27 kg per square meter if accompanied by weight-related comorbidities.

Background material for this hearing are available here.

More details on this meeting are available here.

It will be of interest to see how the panel decides to vote.

AMS
Washington, DC