VIVUS, Inc. (NASDAQ: VVUS) today announced that on August 31, 2011, during the late breaking poster session at the 29th International Epilepsy Congress (IEC) in Rome, Italy, Dr. Alison Pack, Associate Professor of Clinical Neurology, Department of Neurology, Columbia University Medical Center, will present the results of a retrospective study of medical claims data on oral clefts (OC) and major congenital malformations (MCMs) associated with in utero topiramate exposure. The IEC is one of the largest international gatherings of medical professionals focused on the management of patients with epilepsy.
The study was conducted using medical claims and pharmacy prescription data from the Wolters Kluwer Pharma Solutions Source® Lx Patient Longitudinal Database, which identified 778 mother-infant dyads exposed to topiramate within 10 months prior to giving birth. The study also included two non-topiramate-exposed control groups: one comprised of 3,431 dyads exposed to other antiepileptic drugs (AEDs) during pregnancy and a second of 2,307 dyads with a diagnosis of epilepsy, but no exposure to topiramate during pregnancy. In all cohorts, known or suspected teratogens, including valproate, and phenytoin were excluded. The risk of OC and MCM due to topiramate exposure was calculated in comparison to the other AED exposed and the non-topiramate exposed Epilepsy groups. The results are as follows:
The relative risk (95% CI) for the topiramate group vs. other AEDs group for OCs was 1.26 (0.26-6.05) and the relative risk of MCMs was 1.18 (0.80-1.72). For the topiramate vs. the non-topiramate exposed Epilepsy group, the relative risk 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."
SOURCE VIVUS, Inc.