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Topiramate Exposure and Birth Defect Data to be Presented at the 29th International Epilepsy Congress
Date:7/20/2011

was 0.85 (0.18-4.07) for OCs and the relative risk was 0.87 (0.59-1.28) for MCMs. There were no statistically significant differences in OC or MCM frequency between the topiramate and control groups.

"The results of this retrospective study show that in comparison to the other non-teratogenic AED group or non-topiramate exposed epileptic group, topiramate exposure during pregnancy does not appear to significantly increase the risk of oral clefts or major congenital malformations," commented Peter Tam, president of VIVUS, Inc.  "It is important to point out that this is not the ongoing, larger FORTRESS study, which utilizes medical claims databases from different sources than Wolters Kluwer.  This retrospective observational study was conducted to provide us with an early assessment of the teratogenic potential of topiramate.  The FORTRESS results, expected in the fourth quarter of 2011, along with the results from this study, will be used as part of the QNEXA NDA resubmission to the FDA.  To our knowledge, the Wolters Kluwer's study represents the largest retrospective cohort study conducted to date for topiramate and adds to the growing body of information on the teratogenic potential of topiramate as well as other antiepileptic agents."

The study, funded by VIVUS, was conducted by Wolters Kluwer utilizing datasets from the United States and followed patients' Pharmacy and Medical Claims (January 2003 - December 2010) and covered an estimated 177 million lives. Probable exposure during pregnancy was refined using data on script fill date, days of medication supplied, infant birth date, and ICD-9 codes for birth term.

Details of the presentation:

Date: August 31, 2011

Location: Marriott Park Hotel Rome, Italy
Title: Retrospective analysis of major congenital malformations (MCMs) and oral clefts (OC) associated with in utero topiramate (909)
Authors: Pack A(1), Meador K(2), Bhattacharyya
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SOURCE VIVUS, Inc.
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