FDA accepts VIVUS’s NDA application for Avanafil

According to VIVUS, Inc. (NASDAQ: VVUS), the company’s new drug application (NDA) for avanafil, an experimental drug candidate intended to treat erectile dysfunction (ED), has been accepted for review by the US Food and Drug Administration (FDA). April 29, 2012 is the targeted deadline to complete FDA review of avanafil NDA. Results of a pivotal phase III trial comprising more than 1,350 patients reveal that compared to patients on placebo, those treated with avanafil demonstrated considerable improvements in erectile function. In the avanafil development program, the drug was found to be well tolerated and successful in treating patients with general ED and diabetics with ED. The results of the phase III study were further confirmed by a long-term safety study.

President of VIVUS Peter Y. Tam said, “We are pleased with FDA’s acceptance of our NDA. If approved, avanafil could be a valuable treatment alternative for the 18 million men in the United States that suffer from ED.”
About Avanafil: Avanafil is a highly selective phosphodiesterase type 5 (PDE5) intended for the treatment of erectile dysfunction. The investigational oral medication is being licensed from Mitsubishi Tanabe Pharma Corporation. With the exception of certain Asian Pacific Rim countries, VIVUS has global development and commercial rights to avanafil for the treatment of sexual dysfunction.