VIVUS, Inc. announced that a New Drug Application (NDA) has been submitted to the US 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 programme 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 programme. 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 programme and made this filing possible."
The NDA includes results from two placebo-controlled, randomized, double-blind, multicentre 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 programme 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.
The avanafil phase 3 programme consists of three pivotal studies: TA-301 (REVIVE), TA-302 (REVIVE-Diabetes) and TA-303 (REVIVE-RP), as well as a 52-week, open-label, long-term safety study. TA-301, TA-302 and TA-303 were all randomized, double-blind, placebo-controlled phase 3 studies of avanafil in patients with a history of ED for at least six months. Each of the pivotal trials has a similar trial design with patients undergoing a four-week, non-treatment run-in period followed by 12 weeks of treatment. Primary endpoints of the studies are improvement in erectile function as measured by the Sexual Encounter Profile (SEP) and improvements in the EF domain score of the International Index of Erectile Function (IIEF). REVIVE-RP was not required for the NDA filing.
Avanafil is an investigational oral medication being developed for the treatment of erectile dysfunction. Avanafil is a highly selective phosphodiesterase type 5 (PDE5) inhibitor licensed from Mitsubishi Tanabe Pharma Corporation. With the exception of certain Asian Pacific Rim countries, VIVUS owns worldwide development and commercial rights to avanafil for the treatment of sexual dysfunction.
VIVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health.