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REVIVE Trial Results for Avanafil Published in JSM Demonstrate Significant Improvement in Erectile Function
Date:1/17/2012

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 ev
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