New data from phase 3 study of avanafil for treatment of ED announced

Jan 11 2010

VIVUS, Inc. (Nasdaq: VVUS) today announced new data from an analysis of the recently completed phase 3 study (REVIVE TA-301) of avanafil, an investigational drug candidate for the treatment of erectile dysfunction (ED). Patients who attempted intercourse within 15 minutes of dosing were successful 67%, 69% and 72% of the time on 50, 100 and 200 mg of avanafil, respectively, as compared to 29% of the patients on placebo (p<0.05). The previously-disclosed top-line results of the REVIVE study evaluating the safety and efficacy of avanafil in 646 patients showed that all three doses of avanafil met the FDA-defined primary study endpoints 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 magnitude of success in the first 15 minutes was surprising. The previously released results demonstrated rapid onset and a long duration of effect. In order to determine how quickly patients had success with avanafil, an analysis of the results was performed, which showed efficacy in 15 minutes," stated Leland Wilson, chief executive officer of VIVUS. "This new data further strengthens the profile and differentiation of avanafil from other currently available oral ED therapies. We knew from the pharmacokinetic profile that avanafil works very quickly; this data is exciting evidence of how fast avanafil really works."

"From our discussions with patients and physicians, we knew that rapid onset was an important attribute in the selection of an ED therapy. A recent study in 1,900 patients with ED showed that 75% of patients identified rapid effect as an important treatment expectation. Knowing that avanafil can be effective within 15 minutes should create an attractive position in the PDE5 market," stated Charles Bowden, M.D., Senior Director, Clinical Development at VIVUS.

Previously reported highlights of the studies include:

• Nearly 80% of all 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 maintained for all doses across multiple time points beyond six hours
• All FDA-defined primary endpoints were met across all three doses of avanafil
• Avanafil was well tolerated
• There were no drug-related serious adverse events in the study
• Avanafil patients reported low rates of common PDE5i side effects, including headache, flushing and nasal congestion