MOUNTAIN VIEW, Calif., April 9, 2012 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration (FDA) informed VIVUS (Nasdaq:VVUS - News) of an extended Prescription Drug User Fee Act (PDUFA) date for its review of the Qnexa New Drug Application (NDA) from April 17 to July 17, 2012. The three-month extension is a standard extension period.
On April 4, 2012, following the FDA's request, VIVUS submitted the Qnexa Risk Evaluation and Mitigation Strategy (REMS), which was considered a major amendment to the NDA. The submission consisted of proposed REMS materials. Since the receipt date was within three months of the user fee goal date, the FDA is extending the PDUFA date by three months to provide time for a full review of the submission.
"The Qnexa REMS submission is comprehensive, with materials based on ongoing feedback from the FDA since our advisory committee meeting in February," stated Leland F. Wilson, chief executive officer of VIVUS. "We look forward to finalizing our REMS with the FDA while we move forward with our commercialization plans."
The Qnexa NDA 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 or dyslipidemia. Obesity is the second leading cause of preventable death and directly contributes to numerous life-threatening conditions including diabetes, cardiovascular disease, hypertension and stroke.
About Qnexa Extended 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, extended-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.
About VIVUS
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 resubmitted the Qnexa NDA in October 2011, which has a FDA action date of July 17, 2012. On February 22, 2012, in a 20-to-2 vote, the U.S. Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee recommended that Qnexa be granted marketing approval by the FDA for the treatment of obesity in adults. In January 2012, we received the 180-day LOI from the CHMP. 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.
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