VIVUS submits avanafil NDA to FDA for treatment of erectile dysfunction

VIVUS, Inc. (NASDAQ: VVUS) today announced that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) seeking approval of avanafil, its investigational drug for the treatment of erectile dysfunction (ED). The NDA submission follows the successful completion of an extensive phase 3 program for avanafil, which included over 1,350 patients, where avanafil was shown to be well tolerated and effective in treating men with ED.

"This NDA filing is yet another major milestone for VIVUS and the avanafil program. The efficacy was consistent across all patient groups, with success observed in some patients in as early as 15 minutes after dosing.  The drug was well tolerated and had a low dropout rate in all of the clinical trials.  If approved, avanafil could be an attractive treatment alternative for the 30 million men in the United States who suffer from ED," stated Leland F. Wilson, chief executive officer for VIVUS. "The unique profile of potentially faster onset and greater selectivity should allow avanafil to effectively compete in the $4 billion worldwide ED market.  I wish to thank all of the VIVUS employees, investigators, advisors, patients and our development partner, Mitsubishi Tanabe Pharma Corporation, who contributed to the program and made this filing possible."

The NDA includes results from two placebo-controlled, randomized, double-blind, multicenter studies:  REVIVE, which included 646 men from the general population with ED, and REVIVE-Diabetes, which included 390 diabetics.  Also included are the results from the year-long safety study, TA-314, which included 712 continuation patients from the REVIVE and REVIVE-Diabetes studies.  Previously reported highlights from the avanafil development program include:

• All doses tested – 50 mg, 100 mg, and 200 mg – met each of the co-primary efficacy endpoints of the studies
• Erections sufficient for penetration (SEP2) were observed in 77% and 63% of avanafil patients at the 200 mg dose, as compared to 54% and 42% of placebo patients in the REVIVE and REVIVE-Diabetes studies, respectively
• Successful intercourse (SEP3) was achieved in 57% and 40% of avanafil patients at the 200 mg dose, as compared to 27% and 20% of placebo patients in the REVIVE and REVIVE-Diabetes studies, respectively
• Significant improvement in erectile function as measured by IIEF-EF domain score was observed for all doses in avanafil-treated patients
• Across all the phase 3 studies, successful intercourse (SEP3) was observed in some avanafil-treated patients as early as 15 minutes after dosing
• The most common side effects were headache, flushing, nasopharyngitis and nasal congestion
• There were no drug-related serious adverse events reported in the studies