Qnexa phentermine/topiramate: Preliminary data

Additionally, the oral cleft prevalence rate in 1,945 mother-infant dyads that were exposed to topiramate either alone or in combination with other anti-epileptic drugs in the first trimester was 0.36%. In a second control group of 13,614 mother-infant dyads who were not exposed to prior anti-epileptic drugs but had similar medical profiles to that of the first trimester topiramate cohort, the prevalence rate was 0.07%. The study is also evaluating major congenital malformations associated with topiramate. Final results from FORTRESS are expected in 3Q12. 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.

Last July, researchers at Columbia University Medical Center reported data from a retrospective analysis of medical claims and pharmacy prescription data showing that infants exposed to topiramate in utero did not have a significantly increased risk of developing oral clefts or major congenital malformations (see BioCentury, July 25, 2011). ...