VIVUS (VVUS) Reports Topline Results from OC Data from Topiramate Exposure

VIVUS, Inc. (Nasdaq: VVUS) today announced topline preliminary results from its retrospective study of medical claims data on oral clefts (OC) associated with topiramate exposure in utero. The study, known as FORTRESS for Fetal Outcome Retrospective TopiRamate ExpoSure Study, identified 1,945 mother-infant dyads exposed to topiramate either alone (monotherapy) or in combination with other antiepileptic agents (polytherapy) in the first trimester of pregnancy (the "Total Topiramate Cohort"). Among the Total Topiramate Cohort, 1,740 dyads were exposed to topiramate monotherapy (the "Topiramate Monotherapy Cohort"). There were 5 oral clefts in the Topiramate Monotherapy Cohort for a prevalence rate of 0.29% (5/1,740). This prevalence rate was compared to a control group of infants of women who had previously taken antiepileptic drugs including topiramate but not during the pregnancy of interest (the "Formerly Exposed Cohort"). The prevalence rate for the Formerly Exposed Cohort was 0.16% (21/13,512). The prevalence ratio for Topiramate Monotherapy Cohort versus the Formerly Exposed Cohort was 1.88 (center-standardized, 95% CI 0.70–5.03).

The FORTRESS study analyzed data from the Total Topiramate Cohort, the Formerly Exposed Cohort, and a second control group, infants of women with similar medical profiles to the Total Topiramate Cohort regardless of prior antiepileptic drug use (the "Similar Medical Profile Cohort"). The Similar Medical Profile Cohort contained 13,614 dyads. In the Total Topiramate, Formerly Exposed, and Similar Medical Profile Cohorts there were 7, 21 and 9 oral clefts, respectively, for a prevalence of 0.36%, 0.16%, and 0.07%. Prevalence ratios standardized by center were 2.36 (95% CI: 0.99-5.59) for Total Topiramate Cohort versus the Formerly Exposed Cohort, and 5.44 (95% CI: 2.03-14.61) for Total Topiramate Cohort versus Similar Medical Profile Cohort. Results standardized by propensity score and site as well as results adjusting for other covariates, one at a time, yielded very similar results. One data source reported an unexpectedly low prevalence of oral clefts in the Similar Medical Profile Cohort. To evaluate this finding, investigators conducted post-hoc analyses that involved repeated re-sampling from the group of dyads who were eligible for this cohort. Based on this re-sampling, the investigators determined that the oral clefts prevalence observed in the cohort was likely an artificially low estimate due to random error, suggesting that the observed prevalence ratio for the Total Topiramate Cohort versus the Similar Medical Profile Cohort is an over-estimate.

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