EFFICACY GREATER THAN 80 PERCENT SEEN IN AVANAFIL ED TRIAL

VIVUS has announced positive results from a Phase II study to evaluate the effects of Avanafil, its investigational oral phosphodiesterase type 5 (PDE5) inhibitor, in men with erectile dysfunction (ED).

The multicenter, double-blind, randomized, parallel-design study assessed the safety and efficacy of different doses of Avanafil for the treatment of ED. Patients were instructed to attempt sexual intercourse 30 minutes after taking Avanafil, with no restrictions on food or alcohol consumption. Results showed that up to 84 percent of Avanafil doses resulted in erections sufficient for vaginal penetration, as compared to placebo (p<0.001). Avanafil was well tolerated and no serious adverse events were reported.

Following a four-week, non-treatment run-in period, 284 patients were treated for 12 weeks with placebo or Avanafil at various doses. The primary endpoints used to assess treatment efficacy included the percentage of erections sufficient for vaginal penetration and the percentage of erections lasting long enough for successful intercourse.