Avanafil shows benefit against ED in prostate cancer patients post-surgery


According to media information released earlier today by Vivus, Inc., the company’s selective, investigational phosphodiesterase type 5 (PDE5) inhibitor known as avanafil has shown positive results in a randomized, double-blind, multi-center, placebo-controlled Phase III clinical trial for the treatment of erectile dysfunction (ED) in patients after a radical prostatectomy.

As detailed in the company’s media release, the study (also known as REVIVE-RP or TA-303) met all primary endpoints by demonstrating 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). Detailed results of the study are to be presented on June 17, 2011 at the Cancer Survivorship and Sexual Health Symposium in Washington, DC.

Vivus expects to submit a New Drug Application (NDA) to the US Food & Drug Administration later this year to seek approval of avanafil for several indications related to the treatment of erectile dysfunction. To date, no PDE5 inhibitor has ever been approved in the USA specifically for the treatment of erectile dysfunction as a consequence of surgical treatment of prostate cancer.

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