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Dong-A PharmTech Co., Ltd. Announces Positive Results for Udenafil,,Its New Long Acting Drug For Erectile Dysfunction

All Endpoints Met - Up to 88% Efficacy

SEOUL, Korea, March 28, 2007 /PRNewswire/ -- Dong-A PharmTech Co., Ltd. announced today that it has completed a 340 patient phase 2b "at-home" clinical study for udenafil, its new long acting (12 hour half-life) oral phosphodiesterase type 5 (PDE5) inhibitor for erectile dysfunction (ED). The multi-center study conducted in the U.S. was a randomized, double-blind, placebo controlled study, designed to investigate the efficacy and safety of udenafil in patients with ED. Following a 4-week non-drug baseline period, 340 men with ED of broad etiology and severity were randomized to one of four treatment groups: Placebo, udenafil 50mg, udenafil 100mg or udenafil 150mg. The drug treatment period was 12 weeks with evaluations every 4 weeks. The primary efficacy endpoints were the change in the International Index of Erectile Function (IIEF) Erectile Function Domain (EF) score from baseline to final visit; mean vaginal penetration success rates and mean intercourse completion rates calculated from the Sexual Encounter Profile (SEP) questions 2 and 3, respectively. The study had several secondary efficacy measurements including changes in scores from the other IIEF domains, scores from the remaining SEP questions, changes from baseline in the Patient Self-Assessment Questionnaire (PSAE) and the mean Global Assessment Score (GAQ).

All primary efficacy endpoints were statistically significant compared to placebo. The mean vaginal penetration success rates were 72% (50mg), 88% (100mg) and 82% (150mg) and significantly (p<0.001) higher compared to the 60% observed in the placebo group. The mean intercourse completion rates were 53% (50mg), 66% (100mg) and 69% (150mg) and significantly (p<0.001) higher compared to the 38% observed in the placebo group. Patients reporting improved erections after the 12-week course of therapy were 58% (50mg), 80% (100mg) and 73% (150mg) and signif
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