MOUNTAIN VIEW, Calif., June 26, 2013 (GLOBE NEWSWIRE) -- VIVUS, Inc. (Nasdaq:VVUS) (the "Company") today announced that the European Commission (EC) has adopted the implementing decision granting marketing authorization for SPEDRA™ (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.
"SPEDRA represents another significant regulatory approval for VIVUS; it is a tremendous accomplishment both for the Company and for our European team. The unique characteristics of SPEDRA will offer the estimated 20 million European ED patients an important treatment option," said Peter Tam, president of VIVUS, Inc. "We recently announced positive results from a multicenter, placebo-controlled study, TA-501. In this study, ED patients achieved statistically significant improvement over placebo in the mean proportion of attempts that resulted in erections sufficient for successful intercourse as early as 10 minutes following administration for the 200 mg dose and 12 minutes following administration for the 100 mg dose. We believe the recent study results along with the EU approval significantly enhance the value of the avanafil franchise and will be attractive to potential partners worldwide."
"Approval of this NCE for ED is another important drug development milestone for VIVUS," stated Wesley Day, PhD, vice president of clinical development for VIVUS, Inc. "SPEDRA's approval is a testament to the expertise and dedication of our European team of advisors and consultants. The US and EU approvals will support submissions in a number of countries throughout the world. We also extend our thanks to Mitsubishi Tanabe Pharma Corporation, our partner in this effort."