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VIVUS Announces Positive Phase 3 Results of Avanafil in Radical Prostatectomy Patients
Date:5/25/2011

MOUNTAIN VIEW, Calif., May 25, 2011 /PRNewswire/ -- VIVUS, Inc. (NASDAQ: VVUS) today announced positive results from a phase 3, placebo-controlled clinical trial of the investigational drug avanafil for the treatment of erectile dysfunction (ED) in patients following a radical prostatectomy. The study (REVIVE-RP, TA-303) met all primary endpoints by demonstrating improvement from baseline in erectile function as measured by the Sexual Encounter Profile (both SEP2 and SEP3) and improvements in the International Index of Erectile Function (IIEF). The detailed results of the study will be presented on June 17, 2011 at the Cancer Survivorship and Sexual Health Symposium in Washington, DC.  

"Patients who have undergone a radical prostatectomy often have significant erectile dysfunction.  Despite advancements in surgery, it can take several months or years to normalize erections.  Radical prostatectomy patients are difficult to treat but the positive results of avanafil in these patients suggest that, if approved, avanafil could be an attractive treatment option," commented John Mulhall, M.D., Director, Male Sexual & Reproductive Medicine Program, Memorial Sloan Kettering Cancer Center and an investigator in the study. "The trial met all the primary endpoints and detailed results of the study will be presented during the upcoming Cancer Survivorship Symposium to be held in Washington DC."

Consistent with other avanafil clinical studies, successful intercourse as measured by SEP 3 was observed as early as 15 minutes after the administration of avanafil. The most common side effects were headache, flushing and nasopharyngitis, and dropouts due to adverse events were low.  There were no serious adverse events reported in the study.

The results of the TA-303 study are not required for the avanafil New Drug Application (NDA), but the fi
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SOURCE VIVUS, Inc.
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