An open‐label, long‐term evaluation of the safety, efficacy and tolerability of avanafil in male patients with mild to severe erectile dysfunction

Summary Aim:  Determine the long‐term efficacy, safety and tolerability of avanafil, a highly specific, rapidly absorbed phosphodiesterase type 5 inhibitor in male patients with mild to severe erectile dysfunction (ED), with or without diabetes. Methods:  This was a 52‐week, open‐label extension of two 12‐week, randomised, placebo‐controlled, phase 3 trials. Patients were assigned to avanafil 100 mg, but could request 200 mg (for increased efficacy; ‘100/200‐mg’ group) or 50 mg (for improved tolerability). Primary end points included percentage of sexual attempts ending in successful vaginal penetration [Sexual Encounter Profile 2 (SEP2)] and intercourse (SEP3) and erectile function domain score per the International Index of Erectile Function (IIEF‐EF). Results:  Some 712 patients enrolled; 686 were included in the intent to treat population and contributed to the data. All primary end points showed sustained improvement. SEP2 and SEP3 success rates improved from 44% to 83% and from 13% to 68% (100‐mg group) and from 43% to 79% and from 11% to 66% (100/200‐mg group), respectively. Mean IIEF‐EF domain scores improved from 13.6 to 22.2 (100‐mg group) and from 11.9 to 22.7 (100/200‐mg group). Avanafil was effective in some patients ≤ 15 min and > 6 h postdose. Sixty‐five per cent (112/172) of ‘nonresponders’ to avanafil 100 mg responded to the 200‐mg dose. The most common (≥ 2%) treatment‐emergent adverse events were headache, flushing, nasopharyngitis and nasal congestion; < 3% of patients discontinued therapy because of adverse events. Conclusions:  The long‐term tolerability and improvement in sexual function, coupled with rapid onset, suggest that avanafil is well suited for the on‐demand treatment of ED.