Avanafil: Phase III data

The open-label, U.S. Phase III TA-314 safety trial in 712 patients who completed the REVIVE (TA-301) or REVIVE-Diabetes (TA-302) trials showed that 50-200 mg oral avanafil met the co-primary endpoints of significantly improving ED as measured by SEP questions 2 and 3 and IIEF scores from baseline. Specifically, 80% of sexual attempts in patients treated with avanafil had erections sufficient for vaginal penetration as measured by SEP question 2 and 67% of patients experienced successful intercourse as measured by SEP question 3. Avanafil also led to a significant 10.3 point improvement from baseline in IIEF score at the end of treatment. Avanafil was well tolerated with headache, flushing, nasopharyngitis and nasal congestion reported as the most common side effects. ...