VIVUS, Inc. (Nasdaq: VVUS) today announced positive results from REVIVE (TA-301), a phase 3 pivotal study evaluating the safety and efficacy of avanafil, an investigational drug candidate for the treatment of erectile dysfunction (ED), in 646 patients. The REVIVE study met all primary endpoints across the three doses studied by demonstrating statistically significant improvement in erectile function as measured by the Sexual Encounter Profile (SEP) and improvements in the International Index of Erectile Function (IIEF) score. The pivotal study, conducted under a Special Protocol Assessment with the U.S. Food and Drug Administration (FDA), also demonstrated successful intercourse in 30 minutes or less, and a favorable side-effect and safety profile.
"Erectile dysfunction is a significant problem among more than half of all men over the age of 40. While sales of currently available ED therapies exceed $3.8 billion a year, persistent switching by patients suggests that patients are less than satisfied with current therapies," stated Leland Wilson, chief executive officer of VIVUS. "These phase 3 avanafil data not only confirm the robust efficacy we've seen in earlier trials, but potentially differentiate avanafil from other PDE5 inhibitors when it comes to side effects and time-to-onset of efficacy. We are confident that avanafil can effectively compete in the oral ED therapy market."
Highlights of the study include:
- Nearly 80% of sexual attempts among patients on the 200 mg dose of avanafil had erections sufficient for intercourse (SEP2)
- Full efficacy, as measured by successful intercourse, was reported by avanafil patients in 30 minutes or less
- Full efficacy was maintained for all doses across multiple time points from 30 minutes to beyond six hours
- All FDA-defined primary endpoints were met across all three doses of avanafil
- Avanafil was well tolerated as demonstrated by a high retention rate (85%)
- There were no drug-related serious adverse events in the study
- Avanafil patients had low reports of common PDE5i side effects
"Many patients living with chronic ED become frustrated by the occasional treatment-limiting side effects associated with currently available therapies. Patients often switch therapies in search for an improved experience," stated LeRoy Jones, MD, Clinical Associate Professor, Urology, University of Texas Health Science Center, San Antonio and an avanafil trial investigator. "The efficacy and safety data for avanafil underscore the potential role this next-generation PDE5 inhibitor may play in the lives of the millions of men living with ED, searching for new treatment options."
Dr. Jones added, "Another important consideration of patients is how quickly their ED therapy works; these data suggesting that avanafil achieves a full effect in 30 minutes or less, with a window of opportunity for intercourse extending beyond six hours, would be a welcome option for ED treatment."
The REVIVE study was a randomized, double-blind, placebo-controlled efficacy and safety study that evaluated three doses of avanafil in men with a history of general ED. The results of the phase 3 study showed: