MOUNTAIN VIEW, Calif. and CHESTERBROOK, Pa., Jan. 21, 2014 (GLOBE NEWSWIRE) -- VIVUS, Inc. (Nasdaq:VVUS) and Auxilium Pharmaceuticals, Inc. (Nasdaq:AUXL) today announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental application that proposes to revise the STENDRA ™ (avanafil) prescribing information with efficacy and safety information from Study TA-501, entitled "A Randomized, Double-Blind, Placebo-Controlled Evaluation of Avanafil for On-Demand Treatment of Men with Erectile Dysfunction." The PDUFA date for the supplemental filing is September 20, 2014.
VIVUS had previously announced positive results from this multicenter, placebo-controlled study designed to assess the efficacy of two dosage strengths of STENDRA approximately 15 minutes after dosing.
In the 440-patient study conducted at 30 sites in the U.S., STENDRA patients achieved statistically significant improvement versus placebo in the mean proportion of attempts that resulted in erections sufficient for successful intercourse as early as 10 minutes for the 200 mg dose and 12 minutes for the 100 mg dose following administration. The currently approved prescribing information recommends administration approximately 30 minutes before sexual activity.About Avanafil STENDRA (avanafil) is approved by the FDA in the U.S. for the treatment of erectile dysfunction. STENDRA is rapidly absorbed and should be taken 30 minutes before sexual activity on an as-needed basis. STENDRA should not be taken more than once per day and may be taken without regard to food and with modest alcohol consumption. Auxilium Pharmaceuticals, Inc. has exclusive marketing rights to STENDRA in the U.S. and Canada and is in the early stages of commercializing STENDRA in the U.S. STENDRA is currently available through retail and mail order pharmacies. Auxilium offers programs that will help patients with out-of-pocket costs. SPEDRA ™, the trade name for avanafil in the European Union (EU), is approved by the European Medicines Agency (EMA) for the treatment of erectile dysfunction 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 erectile dysfunction in over 40 European countries plus Australia and New Zealand. 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 in discussions with other parties for the commercialization rights to its remaining territories.