Phase 3 Study of Avanafil for Erectile Dysfunction
Vivus has announced results from their Phase 3, REVIVE (TA-301) study of avanafil for the treatment of erectile dysfunction (ED). 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.
Avanafil is a highly selective phosphodiesterase type 5 (PDE5) inhibitor.
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