European Approval

European approval of stendraVIVUS,Inc. announced that a Marketing Authorization Application (MAA) has been accepted by the European Medicines Agency (EMA) for the review of avanafil for treatment of erectile dysfunction, its investigational drug for the treatment of erectile dysfunction (ED). The EMA submission follows the successful completion of an extensive phase 3 program for avanafil, which included over 1,350 patients.

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.

Results showed significant improvement in erectile function as measured by IIEF-EF domain score was observed for all doses in avanafil-treated patients and successful intercourse (SEP3) observed in some avanafil-treated patients as early as 15 minutes after dosing. The most common side effects of Stendra were headache, flushing, nasopharyngitis and nasal congestion. There were no drug-related serious adverse events reported in the studies

A Marketing Authorization Application is an application to the relevant authority, typically the UK’s MHRA or the European Commission’s Committee for Medicinal Products for Human Use (CHMP) to market a drug or medicine. This is equivalent to the U.S. Food and Drug Administration New Drug Application (NDA).

The U.S. FDA approved Avanafil in April 2012.

In South Korea, avanafil is approved and is marketed by JW Pharma under the brand name Zepeed.

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