VIVUS, Inc. (Nasdaq: VVUS) today announced that data from the previously reported phase 3 pivotal REVIVE (TA-301) study, evaluating the safety and efficacy of the investigational drug avanafil for the treatment of erectile dysfunction (ED), were presented at the American Urological Association (AUA) 2010 Annual Meeting. The data, "Avanafil for the Treatment of Erectile Dysfunction: Results of a Phase 3, Multi-Center, Randomized, Double Blind, Placebo-Controlled Clinical Trial," were presented by Irwin Goldstein, MD, clinical professor of surgery, University of California, San Diego and director of sexual medicine at Alvarado Hospital, San Diego, California. The presentation marks the first time these results have been shared with the medical community at a major medical meeting.
The REVIVE study met all primary endpoints across the three doses studied by demonstrating statistically significant improvements in erectile function as measured by the Sexual Encounter Profile (SEP) and improvements in the International Index of Erectile Function (IIEF) score. Successful intercourse was also reported in as little as 15 minutes and beyond six hours in subjects who attempted intercourse at those time points. Avanafil was well tolerated and demonstrated a favorable side-effect profile with low rates of typical PDE5 inhibitor-like adverse events.
"Many men living with ED often become frustrated by the side effects associated with currently available therapies, or by the length of time it takes for their ED therapy to become effective. Patients are continually in search of treatment options which may help provide a more satisfactory experience in less time," stated Dr. Goldstein. "The efficacy and safety seen with avanafil in this 'real world' study setting is impressive, and its fast onset of action and sustained activity differentiates this PDE5 inhibitor from other therapies. I am encouraged by these results, and the potential role avanafil may play in the lives of men living with chronic ED."
Highlights of the pivotal study, conducted under a Special Protocol Assessment with the U.S. Food and Drug Administration (FDA), include:
- Nearly 80% of all sexual attempts among patients on the 200 mg dose of avanafil had erections sufficient for intercourse (SEP2)
- Treatment with avanafil significantly improved erectile function in a dose-dependent manner; the percentage of subjects achieving a normal IIEF-EF domain score was greater across all doses of avanafil compared to placebo
- Successful intercourse was reported by avanafil patients attempting intercourse in 15 minutes or less and beyond six hours in patients attempting intercourse at those time points
- There were no drug-related serious adverse events in the study
- Avanafil patients reported low frequency of common PDE5i side effects
"More than half of all men over the age of 40 are living with ED, yet research shows that men are dissatisfied with currently available PDE5i therapies," stated Leland Wilson, chief executive officer of VIVUS. "We are honored to have Dr. Goldstein to be the first to share these results with the urology community and look forward to filing an NDA in the first half of 2011."
The most commonly reported side effects in patients taking avanafil included headache, flushing and nasal congestion.
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