VIVUS Inc held an End-of-Review meeting with the Food and Drug Administration (FDA) for the New Drug Application (NDA) for QNEXA, an investigational drug being developed to address weight loss, type 2 diabetes, and obstructive sleep apnea.
The meeting occurred on January 19 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 health,care 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 that 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 dialogue with the FDA on the planned resubmission of the QNEXA NDA.