VIVUS, Inc. (Nasdaq: VVUS) today announced new data from an analysis of the recently completed phase 3 study (REVIVE TA-301) of avanafil, an investigational drug candidate for the treatment of erectile dysfunction (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<0.05). 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.
"The magnitude of success in the first 15 minutes was surprising. The previously released results demonstrated rapid onset and a long duration of effect. In order to determine how quickly patients had success with avanafil, an analysis of the results was performed, which showed efficacy in 15 minutes," stated Leland Wilson, chief executive officer of VIVUS. "This new data further strengthens the profile and differentiation of avanafil from other currently available oral ED therapies. We knew from the pharmacokinetic profile that avanafil works very quickly; this data is exciting evidence of how fast avanafil really works."