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VIVUS Reports Topline Findings From FORTRESS
Date:12/21/2011

MOUNTAIN VIEW, Calif., Dec. 21, 2011 /PRNewswire/ -- 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 prevalence ratio for oral clefts in FORTRESS is within the recently reported range for topiramate from several large studies," commented Peter Tam, president of VIVUS, Inc.  "We have shared these results with the FDA. We continue to work closely with the FDA during their review of the NDA and as we prepare for the upcoming Advisory Committee meeting expected in the first quarter of 2012."

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 (t
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SOURCE VIVUS, Inc.
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