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FDA Requests Birth-Defect Data for Qnexa

MOUNTAIN VIEW, Calif., Jan. 21, 2011 /PRNewswire/ -- VIVUS, Inc. (Nasdaq:VVUS - News) today announced that it held an End-of-Review meeting with the Food and Drug Administration (FDA) for the New Drug Application (NDA) for QNEXA®, an investigational drug for the treatment of obesity. The meeting occurred on January 19th at the FDA's offices in Maryland and was attended by senior members of the FDA and VIVUS' management and consultants. At this meeting the FDA requested that VIVUS assess the feasibility of analyzing existing healthcare databases to determine the historical incidence of oral cleft in offspring of women treated with topiramate for migraine prophylaxis (100 mg).

Based on discussions at the meeting, VIVUS believes the FDA's additional request stems from two published reports which cited two oral clefts in the UK Epilepsy and Pregnancy Register (Hunt et al., July 2008) and four, including two isolated cleft lips, from the North American AED Pregnancy Registry (Hernandez-Diaz et al., June 2010). In the QNEXA® studies, which included 15 births from women exposed to QNEXA® or topiramate, there were no reports of any fetal malformations. The timing of the planned resubmission of the QNEXA® NDA will be determined after agreement with the FDA is reached on the feasibility assessment. VIVUS anticipates continued dialog with the FDA on the planned resubmission of the QNEXA® NDA.

About QNEXA® Controlled Release Capsules
QNEXA® [kyoo-nek-suh] is an investigational drug 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 together 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.

Source: Vivus

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