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VIVUS Reports First Quarter 2011 Financial Results
Date:5/2/2011

in the offspring of women who were exposed to topiramate during pregnancy. We have reached agreement, subject to the finalization of the written protocol, with the FDA on the retrospective observational study objectives and design, primary endpoints, and eligibility criteria. 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. The retrospective observational study, will be called FORTRESS, for Fetal Outcome Retrospective TopiRamate ExpoSure Study. In addition, we discussed with the FDA a potential resubmission of the QNEXA NDA for a limited indication, which would include only men and women of non-child bearing potential. Agreement on the content of such a submission has also been reached, should we choose to pursue a limited indication. The final indication and timing of the resubmission will be dependent upon the results of the retrospective observational study. Our goal is to resubmit the QNEXA NDA in the fourth quarter of 2011. We have confirmed with the FDA that any resubmission will be considered a Class 2 resubmission with a 6-month review goal. The FDA has also indicated that a resubmission would likely be discussed at a second advisory committee meeting.  

About VIVUS VIVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health. The company's lead investigational product in clinical development, QNEXA, has completed phase 3 clinical trials for the treatment of obesity and is currently being considered for approval by US and EU regulators. VIVUS received a Complete Response Letter, or CRL, to the initial QNEXA NDA on October 28, 2010. QNEXA is also in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea. In the area of sexual health, VIVUS is in phase 3 development
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