VIVUS Inc. (VVUS) announced new data from an analysis of the recently completed phase 3 study or REVIVE TA-301 of avanafil, an investigational drug candidate for the treatment of erectile dysfunction or ED. Patients who attempted intercourse within 15 minutes of dosing were successful 67%, 69% and 72% of the time on 50, 100 and 200 mg of avanafil, respectively, as compared to 29% of the patients on placebo (p<>
The previously-disclosed top-line results of the REVIVE study evaluating the safety and efficacy of avanafil in 646 patients showed that all three doses of avanafil met the FDA-defined primary study endpoints by demonstrating statistically significant improvement in erectile function as measured by the Sexual Encounter Profile (SEP) and improvements in the International Index of Erectile Function (IIEF) score.
Previously reported highlights of the studies include nearly 80% of all sexual attempts among patients on the 200 mg dose of avanafil had erections sufficient for intercourse (SEP2); Full efficacy, as measured by successful intercourse, was maintained for all doses across multiple time points beyond six hours; There were no drug-related serious adverse events in the study; Avanafil patients reported low rates of common PDE5i side effects, including headache, flushing and nasal congestion.
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