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Positive Results From Avanafil Post-Prostatectomy Study Featured at Cancer Survivorship Meeting
Date:6/17/2011

erience.

About the Avanafil Phase 3 ProgramThe avanafil phase 3 program consists of three studies: TA-301 (REVIVE), TA-302 (REVIVE-Diabetes), and TA-303 (REVIVE-RP) and a 52-week, open-label, long-term safety study (TA-314). TA-301, TA-302 and TA-303 were all randomized, double-blind, placebo-controlled phase 3 studies of avanafil in 646, 390, and 298 men respectively with a history of ED for at least six months.  Each of the pivotal trials had a similar trial design with patients undergoing a four-week, non-treatment run-in period followed by 12 weeks of treatment. Primary endpoints of the studies were improvement in erectile function as measured by the Sexual Encounter Profile (SEP) and improvements in the EF domain score of the International Index of Erectile Function (IIEF). In all three studies, all doses of avanafil tested met the primary endpoints, with successful intercourse achieved by some subjects in 15 minutes or less after administration.  

TA-314 evaluated avanafil for up to 52-weeks in 712 men, 486 with a history of ED and 226 diabetic men with ED across 40 centers throughout the U.S.  Patients completing REVIVE (TA-301) or REVIVE-Diabetes (TA-302) were eligible for rollover into TA-314.  The study met all primary endpoints by demonstrating sustained improvement from baseline in erectile function as measured by the Sexual Encounter Profile (both SEP 2 and SEP 3) and improvements in the International Index of Erectile Function (IIEF).  The study also indicated a favorable side effect profile and successful intercourse (as measured by SEP 3) in as little as 15 minutes and beyond six hours after dosing, without any restrictions on food or alcohol intake.

VIVUS held a pre-NDA meeting with the FDA to confirm that the pre-clinical and clinical requirements necessary for the filing of an NDA have been met. In total, the phase 3 avanafil clinical program enrolled approximately 1,350 subjects. VIVUS
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SOURCE VIVUS, Inc.
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