Patients achieved an overall improvement in erectile function, as measured by improvement in the International Index of Erectile Function (IIEF). IIEF scores range from 0-30 and measure the severity of erectile dysfunction as follows: severe dysfunction is less than or equal to 10; moderate is 11-16; and mild/minimal is 17-25. Results of the study were:Baseline End of Treatment -------- ---------------- Placebo 12.4 15.3 Avanafil 50 mg 12.7 18.1 Avanafil 100 mg 12.6 20.9 Avanafil 200 mg 12.7 22.2>Patients on avanafil had erections sufficient for penetration as measured by the Sexual Encounter Profile (SEP) question 2:Baseline End of Treatment -------- ---------------- Placebo 47% 54% Avanafil 50 mg 45% 64% Avanafil 100 mg 46% 74% Avanafil 200 mg 48% 77% (p<0.001 vs. placebo) Patients taking avanafil experienced successful intercourse as measured by the SEP question 3:Baseline End of Treatment -------- ---------------- Placebo 13% 27% Avanafil 50 mg 13% 41% Avanafil 100 mg 14% 57% Avanafil 200 mg 12% 57% (p<0.001 vs. placebo)

The most commonly reported side effects in patients taking avanafil (all doses combined) included headache (7.0% vs. 1.2% placebo), flushing (4.6% vs. 0% placebo) and nasal congestion (2.3% vs. 1.2%); there were no reports of visual disturbances such as "blue vision."

VIVUS had previously completed a phase 1 thorough QT prolongation (TQT) study evaluating 100 mg and 800 mg of avanafil. The study was successfully completed with no concern associated with QT prolongation.

"The high selectivity and rapid peak drug concentrations of avanafil make for a very attractive product profile, which is potentially associated with fewer side effects and faster onset of full efficacy - two attributes preferred by men looking for faster and more tolerable options. Full efficacy was seen in 30 minutes or less, and based on patient reported outcomes, the duration of full effect lasted beyond six hours. Based on these results, we believe that avanafil can be positioned as a true on-demand therapy for patients looking for a rapid response," said Wesley Day, PhD, vice president clinical development of VIVUS. "We're pleased with the promising results demonstrated with avanafil, and look forward to further advancing our clinical program toward filing an NDA for avanafil in late 2010 or early 2011."

Mr. Wilson added, "These compelling data for avanafil follow the recent positive phase 3 obesity data for QNEXA, for which we expect to file an NDA before the end of the year, placing VIVUS in the fortunate position of having two late-stage products addressing large markets with significant unmet needs and near-term regulatory and data milestones on the horizon. These assets, combined with our solid cash position, provide VIVUS with significant momentum as we end the year and look ahead towards 2010."

SOURCE VIVUS, Inc.