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.