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REVIVE Trial Results for Avanafil Published in JSM Demonstrate Significant Improvement in Erectile Function
Date:1/17/2012

aluate the number of successful intercourse attempts at various time points post-dosing revealed that avanafil was associated with a significant treatment response as early as 15 minutes and beyond 6 hours after dosing.
  • Nearly 80% of all sexual attempts among patients in the 200mg dose group of avanafil had erections sufficient for intercourse.
  • 72% of study participants had tried at least one other ED treatment.
  • The most common side effects were headache, flushing, nasal congestion and back pain and no drug-related serious adverse events reported.
  • The completion rate in REVIVE was 85.1%  and discontinuations due to adverse events were 1.9%, 3.1%, 2.5% and 3.1%  for the 50mg, 100mg, 200mg and placebo groups, respectively.

    • About the REVIVE Study

    REVIVE (TA-301) was a randomized, double-blind, placebo-controlled, phase 3 study of avanafil in 646 men in the general population with a history of ED for at least six months; 72% of study participants had tried at least one other ED treatment. Patients underwent a four-week, non-treatment run-in period followed by 12 weeks of treatment with one of three doses of avanafil: 50mg, 100 mg and 200mg or placebo. Patients were instructed to attempt sexual intercourse 30 minutes after taking avanafil, with no restrictions on food or alcohol consumption. The primary endpoints of the study were improvement in erectile function as measured by the Sexual Encounter Profile (SEP) and improvements in the International Index of Erectile Function (IIEF) score; secondary endpoints included patient satisfaction with erections and with sexual experience. The phase 3 study was conducted under a Special Protocol Assessment with the U.S. FDA.

    About Avanafil

    Avanafil is an oral investigational drug being developed for the treatment of erectile dysfunction.  Avanafil is a highly selective phosphodiesterase type 5 (PDE5) inhibi
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