June 26, 2013
VIVUS, Inc. today announced that the European Commission (EC) has adopted the implementing decision granting marketing authorization for SPEDRA(TM) (avanafil) for the treatment of erectile dysfunction (ED) in the European Union (EU). The approval of the marketing authorization application (MAA) by the EC follows the positive recommendation by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in April 2013.
SPEDRA, a PDE5 inhibitor, is the first new chemical entity (NCE) approved for ED in over a decade. The global market for ED therapies was approximately $5.5 billion in 2012.
STENDRA, or avanafil, is approved by the FDA for the treatment of erectile dysfunction, or ED, in the U.S. VIVUS, through collaboration arrangements with third parties, intends to market and sell STENDRA in the U.S. and under the trade name SPEDRA in the EU and other territories outside the U.S. Avanafil is licensed from Mitsubishi Tanabe Pharma Corporation (MTPC). 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 currently in discussions with potential partners to commercialize STENDRA in the United States and other territories throughout the world.
It is recommended that STENDRA should be taken approximately 30 minutes before sexual activity. STENDRA should not be taken more than once per day. For more information about STENDRA, please visit www.Stendra.com.