Companies announce positive results with new ED drugs

December 3, 2009

Two investigational oral phosphodiesterase type-5 inhibitors for the treatment of erectile dysfunction have shown positive results in separate studies.

Two investigational oral phosphodiesterase type-5 inhibitors for the treatment of erectile dysfunction have shown positive results in separate studies.

VIVUS, Inc., announced positive data from REVIVE (TA-301), a phase III study evaluating the safety and efficacy of avanafil.

The REVIVE study, which included 646 patients, met all primary endpoints across the three doses studied by demonstrating statistically significant improvement in erectile function as measured by the Sexual Encounter Profile and improvements in the International Index of Erectile Function score. The study also demonstrated successful intercourse in 30 minutes or less and a favorable side effect and safety profile.

Study results included:

Nearly 80% of sexual attempts among patients on a 200-mg dose of avanafil had erections sufficient for intercourse.

  • Full efficacy, as measured by successful intercourse, was reported by avanafil patients in 30 minutes or less.
  • Full efficacy was maintained for all doses across multiple time points from 30 minutes to beyond 6 hours.
  • All FDA-defined primary endpoints were met across all three doses of avanafil.
  • Avanafil was well tolerated, as demonstrated by a high retention rate (85%).

"The efficacy and safety data for avanafil underscore the potential role this next-generation PDE-5 inhibitor may play in the lives of the millions of men living with ED, searching for new treatment options," said trial investigator LeRoy Jones, MD, of University of Texas Health Science Center, San Antonio.

In a separate study, udenafil (Zydena) showed positive results in a multicenter Korean study.

Following a 4-week non-drug baseline period, 240 men with ED were randomized to one of four treatment groups: placebo or one of three doses of udenafil (25, 50, or 75 mg). Patients took one tablet a day for 12 weeks with evaluations every 4 weeks.

The primary efficacy endpoint-change in standard International Index of Erectile Function score from baseline to final visit-was statistically significant for the 50 mg and 75 mg doses compared with placebo, according to a statement from Dong-A Pharmaceutical Co., Ltd. and Dong-A PharmTech, Co. Ltd. The mean vaginal penetration success rates at 12 weeks were 98.7% (75 mg) and 90.3% (50 mg), and both dose levels were statistically significant compared with placebo (pp

Percentages of patients reporting improved erections after the 12-week course of therapy were 88% (75 mg), 75% (50 mg), and 69.5% (25 mg), compared with 35.6% in the placebo group (p

All three active dose levels were well tolerated.