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FDA Issues Complete Response Letter to VIVUS Regarding New Drug Application for QNEXA®
Date:10/28/2010

already submitted REMS plan be continued after the written response from VIVUS has been submitted. The agency also requested a safety update of any new adverse events be submitted to the NDA. Finally, the FDA stated that if approved, phentermine/topiramate would be a Schedule IV drug due to the phentermine component.

As part of the written response, VIVUS plans to compile analyses integrating existing nonclinical and clinical data to provide a comprehensive assessment of the teratogenic potential of topiramate. In addition, VIVUS plans to provide several new analyses to demonstrate QNEXA does not increase the risk for major cardiovascular events, which would include data from our OB-305 and OB-204 studies. In the CRL, no new clinical studies were requested; however, in the event that any of the FDA concerns are not alleviated, additional clinical studies may be required.

"We remain confident in the efficacy and safety profile of QNEXA demonstrated in the clinical development program and look forward to continue working with the FDA towards the approval for the treatment of obesity," said Leland Wilson, chief executive officer of VIVUS. "We are preparing a comprehensive response to the CRL for submission to the FDA in approximately six weeks."

Note to InvestorsVIVUS will hold a conference call to discuss this update on Friday, October 29, 2010, beginning at 8:30 a.m. Eastern Time. Investors can listen to this call by dialing toll-free 877-359-2916 or 224-357-2386. A 30-day archive of the call can be accessed at http://ir.vivus.com/.

To access the webcast of this event, please visit VIVUS' Investors site at http://ir.vivus.com/events.cfm. A replay will also be available on demand from the website at the conclusion of the program.

About ObesityApproximately one-third of American adults (more than 72 million people) are obese, and many more
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SOURCE VIVUS, Inc.
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