MOUNTAIN VIEW, Calif., Nov. 3, 2011 /PRNewswire/ -- VIVUS, Inc. (NASDAQ: VVUS) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the New Drug Application (NDA) for Qnexa® to treat obesity. The company resubmitted the NDA on October 17, 2011.
The agency assigned a six-month, or class 2, review classification to the NDA, establishing April 17, 2012, as the Prescription Drug User Fee Act (PDUFA) target date. The FDA indicated that an advisory committee of the Division of Metabolism and Endocrinology Products (DMEP) will meet to discuss the Qnexa NDA in the first quarter of 2012.
The NDA resubmission seeks approval for the treatment of obesity, including weight loss and maintenance of weight loss for obese patients (BMI > 30 kg/m2), or overweight patients (BMI > 27 kg/m2) with weight-related co-morbidities such as hypertension, type 2 diabetes, dyslipidemia, or central adiposity (abdominal obesity). The proposed labeling includes a contraindication for women of childbearing potential. The resubmission also includes a proposed Risk Evaluation and Mitigation Strategy (REMS).
The resubmission follows an agreement reached in September, 2011 with officials from the FDA DMEP on the filing strategy for Qnexa.
There are an estimated 80 million adult American men and women of non-childbearing potential, based on the NHANES 2008 study, who have a BMI > 30 (obese) or BMI > 27 (overweight) with at least one weight-related health risk, such as diabetes, hypertension or dyslipidemia and are at an increased risk of developing obesity-related cardiovascular and metabolic diseases.
About Qnexa Controlled-Release Capsules
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 behavior. In phase 2 and 3 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 program. The most commonly reported side effects were tingling, dry mouth, constipation and altered taste.
VIVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health. The company's lead investigational product in clinical development, Qnexa®, has completed phase 3 clinical trials for the treatment of obesity and is currently being considered for approval by US and EU regulators. VIVUS received a Complete Response Letter, or CRL, to the initial Qnexa NDA on October 28, 2010. VIVUS has resubmitted an NDA for Qnexa, with an FDA action date of April 17, 2012. Qnexa is also in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea. In the area of sexual health, VIVUS has submitted an NDA for avanafil, a PDE5 inhibitor being studied for the treatment of erectile dysfunction, with an FDA action date of April 29, 2012. For more information about the company, please visit www.vivus.com.