Vivus reports FORTRESS data

Vivus Inc. (NASDAQ:VVUS) reported data showing that topiramate -- a component of the company's obesity product Qnexa -- is associated with a higher prevalence of oral clefts in infants whose mothers received the compound during pregnancy. Data from the retrospective FORTRESS study of medical claims showed the oral cleft prevalence rate associated with topiramate monotherapy in the first trimester was 0.29% compared with 0.16% for a control group of women who did not receive topiramate during pregnancy but had previously received anti-epileptic drugs including topiramate. Vivus said the ratio of cleft prevalence between the groups is "within the recently reported range" for topiramate. The topiramate arm included 1,740 mother-infant pairs. The control group included 13,512 mother-infant pairs.

Topiramate is approved at doses of up to 100 mg/day to treat migraines and 400 mg/day to treat seizures. Vivus' Qnexa is a low-dose combination of phentermine and topiramate. The highest dose of topiramate used in the Phase III program was 92 mg. ...