Avanafil: Additional Phase III data

Additional data from the double-blind, U.S. Phase III REVIVE trial (TA-301) in 646 patients showed that 67%, 69% and 72% of patients treated with 50, 100 and 200 mg oral avanafil, respectively, achieved successful intercourse within 15 minutes of dosing vs. 29% for placebo (p<0.05). Vivus previously reported that all three doses of avanafil met the co-primary endpoint of significantly improving ED as measured by SEP and IIEF score in the trial (see BioCentury, Nov. 23, 2009). The trial has an SPA from FDA and is the first of 4 Phase III trials of avanafil for ED. ...