Vivus And Auxilium Pharma Say FDA Approves SNDA For Stendra - Quick Facts

(RTTNews) - Vivus Inc. (VVUS) and Auxilium Pharmaceuticals, Inc. (AUXL) announced that the U.S. Food and Drug Administration or FDA has approved a supplemental new drug application or sNDA for Stendra (avanafil).

The companies said that STENDRA is now the only FDA-approved erectile dysfunction or ED medication indicated to be taken as early as approximately 15 minutes before sexual activity.

Stendra is a prescription medication in a class of drugs known as phosphodiesterase type 5 (PDE5) inhibitors approved for the treatment of ED in men 18 years or older. STENDRA is available in multiple dosage strengths (50, 100 and 200 mg tablets) and may be taken with or without food and moderate alcohol consumption (up to three drinks). In clinical studies, when compared to placebo, Stendra helped more men achieve an erection in as early as approximately 15 minutes that lasted long enough to successfully complete sexual intercourse.

Spedra, the trade name for avanafil in the European Union (EU), is approved by the European Medicines Agency (EMA) for the treatment of ED in the EU. VIVUS has granted an exclusive license to the Menarini Group through its subsidiary Berlin-Chemie AG to commercialize and promote SPEDRA for the treatment of ED in over 40 European countries plus Australia and New Zealand.

Vivus has granted an exclusive license to Sanofi to commercialize avanafil in Africa, the Middle East, Turkey, and the Commonwealth of Independent States (CIS) including Russia.

Avanafil is 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. Vivus is in discussions with other parties for the commercialization rights to its remaining territories.