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FDA Requests Birth-Defect Data for Qnexa
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.