Vivus reports Phase 3 study results of Avanafil

Avanafil is a highly selective phosphodiesterase type 5 (PDE5) inhibitor, and is licensed from Mitsubishi Tanabe Pharma.

The randomized double-blind placebo-controlled Revive (TA-301) trial of Avanafil enrolled 646 men with a history of ED for at least six months, who 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.

In the study, the primary endpoints were improvement in erectile function as measured by the Sexual Encounter Profile (SEP) and improvements in the International Index of Erectile Function (IIEF) score, while the secondary endpoints included patient satisfaction with erections and with sexual experience.

The findings from the study reported that patients who attempted intercourse within 15 minutes of dosing were successful 64%, 67% and 71% of the time with 50, 100 and 200mg of avanafil treatment, respectively, compared to 27% for placebo.

The Revive trial showed that all three doses of Avanafil were superior to placebo for all the endpoints, following 12-weeks of treatment, without restrictions on food or alcohol.

Currently, Avanafil is under review by the Food and Drug Administration (FDA) for the treatment of ED.