Avanafil long-term phase 3 trial in erectile dysfunction meets primary endpoints

VIVUS, Inc. (NASDAQ: VVUS) today announced that positive results from a pivotal phase 3 open-label clinical trial evaluating long-term safety and efficacy of the investigational drug avanafil for the treatment of erectile dysfunction (ED) were presented at the 2011 Annual Meeting of the American Urological Association in Washington, D.C.  Laurence Belkoff, DO, FACOS, Chairman of the Department of Specialty Surgeries and the Division of Urology at the Philadelphia College of Osteopathic Medicine presented the results during the late-breaking science forum. The top-line results had been previously reported; however, the presentation by Dr. Belkoff marks the first time these results have been presented at a major medical meeting.

The study met all primary endpoints by demonstrating sustained improvement from baseline in erectile function as measured by the Sexual Encounter Profile (both SEP 2 and SEP 3) and improvements in the International Index of Erectile Function (IIEF).  The study also indicated that successful intercourse (as measured by SEP 3) was achieved as early as 15 minutes, consistent with results from previously reported phase 3 double-blind, placebo-controlled studies.

"The avanafil data from the open label, long-term safety study confirm the safety and efficacy results previously observed in the two placebo-controlled trials," commented Dr. Belkoff.  "The safety profile demonstrated during the year-long study and successful intercourse attempts within 15 minutes of dosing suggest avanafil, if approved, may be an attractive treatment option for men with ED."

Highlights of the TA-314 study include:

• Eighty percent (80%) of sexual attempts among patients on avanafil resulted in erections sufficient for intercourse (SEP 2)
• Erectile function as measured by IIEF scores improved over 80% from baseline
• Successful intercourse was achieved as early as 15 minutes
• Avanafil was well tolerated as evidenced by a low rate of discontinuations due to adverse events (<3%)
• The most common side effects reported were headache (5.6%), flushing (3.5%), nasopharyngitis (3.4%) and nasal congestion (2.1%)
• There were no drug-related serious adverse events reported in the study