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VIVUS Provides Regulatory Update on QNEXA
Date:9/15/2011

estimated to have a BMI >30 (obese) or BMI >27 (overweight) with at least one weight-related health risk, such as diabetes, hypertension or dyslipidemia. Of these, over three-quarters, or an estimated 80 million adults, are men and women of non-childbearing potential who are at an increased risk of developing obesity-related cardiovascular and metabolic diseases.

"Topiramate teratogencity data published and presented since our last meeting with the FDA in April 2011 includes two case-control studies utilizing the CDC's National Birth Defects Prevention Study and the Slone Epidemiology Birth Defect Study presented at the 27th International Conference on Pharmacoepidemiology and Therapeutic Risk Management in Chicago; and the Wolters Kluwer Study presented at International Epilepsy Congress in Rome. In addition, a birth defect study from Denmark on Newer Generation Antiepileptic Drugs including topiramate was published in JAMA.  In all of these studies, the authors concluded that topiramate was not a major teratogen," commented Wesley Day, vice-president clinical development.  "The conclusions reached in all of these studies were instrumental in the development of the QNEXA NDA resubmission plan."

About FORTRESSFORTRESS, for Fetal Outcome Retrospective TopiRamate ExpoSure Study, is a retrospective observational study utilizing existing electronic healthcare databases to assess fetal outcomes, in the offspring of women who were exposed to topiramate during the first trimester of pregnancy.  FORTRESS is expected to include approximately 2,500 topiramate exposed mother-infant pairs or dyads and is believed to be the largest retrospective topiramate medical claims study ever completed.  The co-primary endpoints will be the relative risk of major congenital malformations and oral cleft in the offspring of women exposed to topiramate during pregnancy as compared to a control group that was not exposed to topiramate. FORTRESS is ex
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SOURCE VIVUS, Inc.
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