Phase 3 Study of Avanafil for Erectile Dysfunction
Vivus announced positive results from a Phase 3 study (REVIVE-RP, TA-303) of Avanafil for the treatment of erectile dysfunction (ED) following a bilateral, nerve-sparing radical prostatectomy. TA-303, a randomized, double-blind, placebo-controlled, parallel group, multicenter study, analyzed a subgroup of men (n= 298) diagnosed with severe ED who were, on average, 58 years old and 19 months past their surgery dates. Subjects were randomized to 100mg or 200mg Avanafil or placebo and were instructed to take one dose of the study drug 30 minutes prior to initiation of sexual activity.
The data reported for this subgroup analysis showed that Avanafil demonstrated improvement from baseline in erectile function as measured by the Sexual Encounter Profile (both SEP2 and SEP3) and improvements in the International Index of Erectile Function (IIEF). Successful intercourse as measured by SEP 3 was observed as early as 15 minutes after the administration of Avanafil.
Avanafil is a highly selective phosphodiesterase type 5 (PDE5) inhibitor. Vivus expects to file the NDA for Avanafil in the second quarter of 2011.
For more information call (650)-934-5200 or visit www.vivus.com.