Vivus has reported the results from its Phase III Revive study investigating the safety and efficacy of an investigational drug Avanafil, used for the treatment of erectile dysfunction (ED).
Licensed from Mitsubishi Tanabe Pharma, Avanafil is a highly selective phosphodiesterase type 5 (PDE5) inhibitor and is currently under review by the Food and Drug Administration (FDA) for the treatment of ED.
The Revive (TA-301) is a randomised double-blind placebo-controlled trial of Avanafil involving 646 men in the general population with a history of ED for at least six months, of which 72% participants had tried at least one other ED treatment. In the study, patients underwent a four-week, non-treatment run-in period followed by 12 weeks of treatment with one of three doses of Avanafil: 50mg, 100mg and 200mg or placebo.
The primary endpoints of the trial included improvement in erectile function as measured by the sexual encounter profile (SEP) and improvements in the international index of erectile function (IIEF) score, and the secondary endpoints were patient satisfaction with erections and with sexual experience.
The Phase III study showed that patients who attempted intercourse within 15 minutes of dosing were successful 64%, 67% and 71% of the time with 50mg, 100mg and 200mg of Avanafil treatment, respectively, compared with 27% for the placebo. The Revive trial reported that nearly 80% of all sexual attempts among patients in the 200mg dose group of Avanafil had erections sufficient for intercourse, with low rates of side effects.
After 12 weeks of treatment, without restrictions on food or alcohol, all three doses of Avanafil were considerably superior to placebo for all primary endpoints, and a secondary analysis using the sexual encounter profile revealed that the drug showed treatment response as early as 15 minutes and beyond six hours of dosing.
The completion rate in the study 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.