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Positive Results from Long-Term Phase 3 Study of Avanafil Featured at American Urological Association Annual Meeting
Date:5/17/2011

e function as measured by IIEF scores improved over 80% from baseline
  • Successful intercourse was achieved as early as 15 minutes
  • Avanafil was well tolerated as evidenced by a low rate of discontinuations due to adverse events (<3%)
  • The most common side effects reported were headache (5.6%), flushing (3.5%), nasopharyngitis (3.4%) and nasal congestion (2.1%)
  • There were no drug-related serious adverse events reported in the study

  • About the StudyTA-314 was an open-label extension study evaluating the long-term safety, efficacy and tolerability of avanafil in 712 diabetic and non-diabetic men with ED across 40 U.S. centers.  Subjects were eligible to enter into TA-314 upon completion of either TA-301 (REVIVE) or TA-302 (REVIVE-Diabetes) and participation lasted for up to 52 weeks.  On average, subjects entering the study had ED for at least six years, with approximately 29% of cases being characterized as mild in severity, 33% moderate and 38% severe.  All subjects were started on a 100mg dose of avanafil and were instructed to take one dose of study drug 30 minutes prior to initiation of sexual activity.  Subjects were then able to request an increase in dose to 200mg for improved efficacy or a decrease in dose to 50mg for improved tolerability.  The primary endpoints of the study were improvement in erectile function as measured by the Sexual Encounter Profile (SEP) 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 ProgramThe 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. A majority of patients in the study had previou
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    SOURCE VIVUS, Inc.
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