VIVUS, Inc. (NASDAQ: VVUS) today announced topline preliminary results from its FORTRESS study. The study was a retrospective study of existing electronic healthcare databases to assess fetal outcomes, in the offspring of women who were exposed to topiramate during the first trimester of pregnancy. The study was conducted as part of the Qnexa NDA for obesity.
The study showed that there were 5 oral clefts in the Topiramate Monotherapy Cohort (women who had taken topiramate during pregnancy) with a prevalence rate of 0.29% (5/1,740). This was nearly double the prevalence rate of the Formerly Exposed Cohort (women who had taken topiramate prior to pregnancy) of 0.16% (21/13,512).
Vivus noted when it filed the NDA that it had reached agreement with the FDA that the initial resubmission would only include obese men and women of non-child bearing potential. However, it hoped to expand the indication to include obese women of child-bearing potential if the FORTRESS results from today were favourable and planned to file for the full indication in late 2012.
A PDUFA date of April 17, 2012 has been assigned to review Qnexa. In addition, Vivus has been informed that an advisory committee of the Division of Metabolism and Endocrinology Products (DMEP) will meet to discuss the Qnexa NDA in 1Q 2012. According to a draft calendar released earlier this week the FDA Endocrinologic and Metabolic Drugs Advisory Committee is due to meet on February 22 and March 28/29, 2012. It is expected that Qnexa will be up for discussion on one of these dates.