Auxilium Pharmaceuticals presents STENDRA clinical data for ED treatment at SMSNA Scientific Meeting

Nov 20 2014

Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, today announced that data were presented regarding the use of STENDRA^® (avanafil) tablets for the treatment of erectile dysfunction (ED) at the 20^th Annual Fall Scientific Meeting of the Sexual Medicine Society of North America (SMSNA) held in Miami from November 20-23, 2014.

Moderated poster sessions on STENDRA included new analyses from Study 501 that help enable a better understanding of the STENDRA clinical profile and FDA-approved administration time of as early as approximately 15 minutes before sexual activity.

"In my practice, I see ED patients that are looking for a safe and effective treatment with a rapid onset of action and a favorable side effect profile," said Laurence H. Belkoff, D.O., M.Sc., F.A.C.O.S., Chairman of the Department of Specialty Surgeries and the Division of Urology at the Philadelphia College of Osteopathic Medicine. "These study findings further reinforce that STENDRA is an appropriate treatment option with the ability to provide a meaningful benefit to men suffering from ED and a rapid onset of action in many men as early as approximately 15 minutes before sexual activity."

Highlights of the information to be presented include:

• A post-hoc analysis of data from a placebo-controlled, Phase 4 study of STENDRA evaluated men who had at least one attempt at intercourse within approximately 15 minutes of taking the medication. The STENDRA 100 and 200mg doses demonstrated statistically significant improvement in onset of erectogenic effect at approximately 15 minutes compared to placebo, with a mean per-patient proportion of sexual attempts that resulted in at least one successful intercourse within approximately 15 minutes after dosing of 73.3 percent and 71.5 percent, respectively.
• Results of a study examining the proportion of men with ED who reported successful intercourse within the first three doses of STENDRA showed more than 60 percent of patients reported successful intercourse within the first three doses of STENDRA. This compares to about 40 percent with placebo. A higher percentage (75 percent for STENDRA vs. 56 percent for placebo) also reported success after any dose.