Vivus Inc., a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health, announced that a Marketing Authorization Application (MAA) has been accepted by the European Medicines Agency (EMA) for the review of avanafil, its investigational drug for the treatment of erectile dysfunction (ED). The EMA submission follows the successful completion of an extensive phase 3 programme for avanafil, which included over 1,350 patients.

"The unique profile of avanafil, including its onset of action and highly selective profile, make it an attractive treatment alternative for the more than 20 million European men suffering with ED," stated Francesco Montorsi, MD, Professor of Urology and Director of the Urology Research Institute at the Universita' Vita e Salute San Raffaele in Milan, Italy. "Successful intercourse was reported in some patients in as little as 15 minutes after dosing. The comprehensive results from the development programme suggest avanafil, if approved, could effectively compete in the $4 billion worldwide ED market."

Avanafil is an oral investigational drug being developed for the treatment of erectile dysfunction.  Avanafil is a highly selective phosphodiesterase type 5 (PDE5) inhibitor licensed from Mitsubishi Tanabe Pharma Corporation. Vivus owns worldwide development and commercial rights to avanafil for the treatment of sexual dysfunction, with the exception of certain Asian Pacific Rim countries. In South Korea, avanafil is approved and is marketed by JW Pharma under the brand name Zepeed. Vivus has submitted an NDA for avanafil, a PDE5 inhibitor being studied for the treatment of erectile dysfunction, with an FDA action date of April 29, 2012.

The MAA includes results from three placebo-controlled, randomized, double-blind, multicenter studies: REVIVE, which included 646 men from the general population with ED, REVIVE-Diabetes, which included 390 diabetics, and REVIVE-RP, which included 298 men following radical prostatectomy. Also included are the results from the year-long safety study, TA-314, which included 712 continuation patients from the REVIVE and REVIVE-Diabetes studies.

Previously reported highlights from the avanafil development programme include:  All doses tested , 50 mg, 100 mg, and 200 mg, met each of the co-primary efficacy endpoints; Erections sufficient for penetration (SEP2) were observed in 77% and 63% of avanafil patients at the 200 mg dose, as compared to 54% and 42% of placebo patients in the REVIVE and REVIVE-Diabetes studies, respectively; Successful intercourse (SEP3) was achieved in 57% and 40% of avanafil patients at the 200 mg dose, as compared to 27% and 20% of placebo patients in the REVIVE and REVIVE-Diabetes studies, respectively; Significant improvement in erectile function as measured by IIEF-EF domain score was observed for all doses in avanafil-treated patients; Across all the phase 3 studies, successful intercourse (SEP3) was observed in some avanafil-treated patients as early as 15 minutes after dosing; The most common side effects were headache, flushing, nasopharyngitis and nasal congestion. There were no drug-related serious adverse events reported in the studies