Investigational PDE-5 inhibitor found efficacious in ED, well tolerated

Up to 84% of doses with the investigational oral phosphodiesterase type-5 inhibitor avanafil resulted in erections sufficient for vaginal penetration compared with placebo (p<.001), according to results from a phase II, multicenter study. The treatment was well tolerated with no serious adverse events, according to VIVUS, Inc., which sponsored the study.

Following a 4-week, non-treatment run-in period, 284 patients were treated for 12 weeks with avanafil or placebo at various doses. Patients were instructed to attempt sexual intercourse 30 minutes after taking avanafil, with no restrictions on food or alcohol consumption.

According to the authors, avanafil produced erections sufficient for vaginal penetration on 76%, 79%, 80%, and 84% of sexual attempts on 50-mg, 100-mg, 200-mg, and 300-mg doses, respectively (p<.05). Erections lasting long enough for successful intercourse were achieved on 54%, 59%, 62%, and 64% of attempts, respectively (p<.0001).

"The ability to initiate intercourse in 30 minutes, which is half the time as compared to the recommended initiation time of two of the currently approved PDE-5 inhibitors, while maintaining a high degree of efficacy, should help differentiate avanafil and give men a meaningful option to treat their ED," said Joel Kaufman, MD, one of the study investigators. "The short half-life of avanafil also offers an important alternative to the currently marketed products."

The study has not been published but is expected to be presented at meetings this fall, a VIVUS spokesman said.