Avanafil: Phase III data

Data from the double-blind, U.S. Phase III REVIVE trial (TA-301) in 646 patients showed that all 3 doses of oral avanafil met the co-primary endpoints of significantly improving ED as measured by SEP and IIEF score vs. placebo. Specifically, 50, 100 and 200 mg avanafil led to improvements from baseline in IIEF score to the end of treatment of 5.4, 8.3 and 9.5, respectively, vs. 2.9 points for placebo (p<=0.001 for all). The 3 doses of avanafil increased the proportion of patients from baseline who had erections sufficient for vaginal penetration as measured by SEP question 2 by 19%, 28% and 29%, respectively, vs. 7% for placebo (p<0.001 for all). Avanafil also increased the proportion of patients from baseline who experienced successful intercourse as measured by SEP question 3 by 28%, 43% and 45%, respectively, vs. 14% for placebo (p<0.001 for all). Avanafil was well tolerated with no drug-related serious adverse events. Patients underwent a 4-week, non-treatment run-in period followed by 12 weeks of avanafil treatment. The trial has an SPA from FDA and is the first of 4 Phase III trials of avanafil for ED. Data for the remaining 3 trials are expected next year. ...