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Positive Results From Avanafil Post-Prostatectomy Study Featured at Cancer Survivorship Meeting
Date:6/17/2011

have been unable to return to normal erectile function following their surgery."

Highlights of the TA-303 study include:

  • Treatment with both doses of avanafil (100 mg and 200 mg) was associated with significant improvements in each of the co-primary endpoints, SEP2, SEP3 and IIEF-EF in comparison with placebo (p <0.001)
  • Patients treated with 100 mg and 200 mg of avanafil improved their ability to have successful intercourse (SEP3) four- and five-fold, respectively, from the start of treatment
  • Treatment with avanafil improved erectile function in a dose-dependent manner with significant increases in the IIEF scores from the beginning of treatment through the end of treatment.  Erectile function scores increased 38% and 55% for patients on the 100 mg and 200 mg doses, respectively, as compared to the placebo group with an increase of 1%
  • The most commonly reported side effects in patients taking avanafil included headache, flushing, and nasopharyngitis
  • There were no serious adverse events or deaths reported in the study

  • About the StudyTA-303 was a randomized, double-blind, placebo-controlled, parallel group, multicenter study of the safety and efficacy of avanafil in the treatment of erectile dysfunction following bilateral, nerve-sparing, radical prostatectomy in 298 men with ED.  On average, subjects entering the study were 58 years old, 19 months past their surgery dates with documented severe ED.  Subjects were randomized to 100 mg or 200 mg avanafil or placebo and were instructed to take one dose of study drug 30 minutes prior to initiation of sexual activity.  The study had a four-week run-in period followed by 12 weeks of treatment.  The primary endpoints of the study were improvements in erectile function as measured by the SEP2 and SEP3 and improvement in the EF-Domain of the IIEF score; secondary endpoints included patient satisfaction with erections and with sexual exp
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    SOURCE VIVUS, Inc.
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