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REVIVE Trial Results For Avanafil Published In JSM Demonstrate Significant Improvement In Erectile Function

MOUNTAIN VIEW, Calif., Jan. 17, 2012 /PRNewswire/ -- VIVUS, Inc. (NASDAQ: VVUS) today announced that results from the REVIVE study were published in The Journal of Sexual Medicine (JSM), a peer-reviewed journal with broad, multidisciplinary readership. REVIVE (TA-301) was a randomized, placebo-controlled, phase 3 study evaluating the safety and efficacy of avanafil, an investigational drug currently under review by the Food and Drug Administration (FDA) for the treatment of erectile dysfunction (ED).  In addition to significant improvements in erectile function and low rates of side effects common to phosphodiesterase type 5  inhibitors, the study also found that patients who attempted intercourse within 15 minutes of dosing were successful 64%, 67% and 71% of the time with 50, 100 and 200mg of avanafil treatment, respectively, versus 27% for placebo (p < 0.0001). The data suggest that avanafil may provide a rapid-onset, well-tolerated and effective treatment option for erectile dysfunction.

"While PDE-5 inhibitors are currently used as first-line therapy for treatment of ED in the general population, what's new and novel about avanafil is that it has a fast onset of action and high selectivity," said lead Investigator Irwin Goldstein, MD, Director of San Diego Sexual Medicine at Alvarado Hospital. "For patients, this means that avanafil, if approved, could be taken on-demand with potentially fewer side effects." 

An overview of the results as published in JSM is as follows:
  • Following 12 weeks of treatment, without restrictions on food or alcohol, all three doses of avanafil (50mg, 100mg and 200mg) were significantly superior to placebo for all primary endpoints (p </= 0.001). 
  • A secondary analysis using Sexual Encounter Profile, question 3 (SEP 3) to evaluate the number of successful intercourse attempts at various time points post-dosing revealed that avanafil was associated with a significant treatment response as early as 15 minutes and beyond 6 hours after dosing.
  • Nearly 80% of all sexual attempts among patients in the 200mg dose group of avanafil had erections sufficient for intercourse.
  • 72% of study participants had tried at least one other ED treatment.
  • The most common side effects were headache, flushing, nasal congestion and back pain and no drug-related serious adverse events reported.
  • The completion rate in REVIVE was 85.1%  and discontinuations due to adverse events were 1.9%, 3.1%, 2.5% and 3.1%  for the 50mg, 100mg, 200mg and placebo groups, respectively.

About the REVIVE Study

REVIVE (TA-301) was a randomized, double-blind, placebo-controlled, phase 3 study of avanafil in 646 men in the general population with a history of ED for at least six months; 72% of study participants had tried at least one other ED treatment. Patients underwent a four-week, non-treatment run-in period followed by 12 weeks of treatment with one of three doses of avanafil: 50mg, 100 mg and 200mg or placebo. Patients were instructed to attempt sexual intercourse 30 minutes after taking avanafil, with no restrictions on food or alcohol consumption. The primary endpoints of the study were improvement in erectile function as measured by the Sexual Encounter Profile (SEP) and improvements in the International Index of Erectile Function (IIEF) score; secondary endpoints included patient satisfaction with erections and with sexual experience. The phase 3 study was conducted under a Special Protocol Assessment with the U.S. FDA.

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