Avanafil ( Stendra, Spedra, Zepeeed ) is an oral phosphodiesterase type 5 inhibitor indicated for the treatment of erectile dysfunction.
Avanafil is rapidly absorbed after oral administration, with a median time to maximum plasma concentration of 30 to 45 min.
In a 12-week, randomized, double-blind, placebo-controlled, multicentre trial in patients with erectile dysfunction, Avanafil 50, 100 and 200 mg recipients had significantly greater improvements from baseline than placebo recipients in mean international index of erectile dysfunction-erectile function domain scores and in successful vaginal penetration and sexual intercourse attempts ( coprimary endpoints ). Treatment effects were significantly larger in Avanafil 100 and 200 mg recipients than 50 mg recipients.
For Avanafil recipients, approximately two-thirds of attempts at sexual intercourse that were made prior to 15 min, or more than 6 h, after drug administration were successful, compared with approximately one-quarter of attempts made during these time periods by placebo recipients.
In trials in patients with erectile dysfunction in association with diabetes mellitus, and after nerve-sparing radical prostatectomy, Avanafil 100 or 200 mg was significantly more efficacious than placebo for primary and most secondary endpoints.
Avanafil was generally well tolerated in the above-mentioned studies.
In a pooled analysis of three clinical trials, less than or equal to 2 % of Avanafil and placebo recipients discontinued treatment because of adverse events.
During extended treatment with avanafil for greater than 52 weeks, 2.8 % of patients discontinued treatment because of adverse reactions and there were no drug-related serious adverse events. ( Xagena )
Source: Drugs Aging, 2013