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

nal study report will be submitted to the FDA upon completion.  VIVUS expects to file the NDA for avanafil in the second quarter of 2011.

About the StudyTA-303 was a randomized, double-blind, placebo-controlled, parallel group, multicenter study of the safety and efficacy of avanafil in the treatment of erectile dysfunction following bilateral, nerve-sparing, radical prostatectomy in 298 men with ED.  On average, subjects entering the study were 58 years old, 19 months past their surgery dates and diagnosed with severe ED.  Subjects were randomized to 100mg or 200mg avanafil or placebo and were instructed to take one dose of study drug 30 minutes prior to initiation of sexual activity.  The study had a four-week run-in period followed by 12 weeks of treatment.  The primary endpoints of the study were improvement in erectile function as measured by the SEP2 and SEP3 and improvements in the EF-Domain of the IIEF score; secondary endpoints included patient satisfaction with erections and with sexual experience.

About the Avanafil Phase 3 ProgramIn addition to TA-303, the avanafil phase 3 program consists of three pivotal studies:  TA-301 (REVIVE), TA-302 (REVIVE-Diabetes), and TA-314. TA-301 and TA-302 were randomized, double-blind, placebo-controlled phase 3 studies of avanafil in 646 and 390 men, respectively, with a history of ED for at least six months. Each of these 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 are 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 both the TA-301 and TA-302 studies, all doses of avanafil met the primary endpoints, with successful intercourse achieved by some subjects as early as 15 minutes after dosing. TA-314 was an open
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SOURCE VIVUS, Inc.
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