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Zydena is Efficacious in Once Daily Dosing for Erectile Dysfunction/Positive BPH Results
Date:11/18/2009

SEOUL, South Korea, Nov. 18 /PRNewswire/ -- Dong-A Pharmaceutical Co., Ltd. and Dong-A PharmTech, Co. Ltd. announced today that it has completed a 240 patient once-a-day dosing clinical study of udenafil, its new long acting phosphodiesterase type 5 (PDE-5) inhibitor for erectile dysfunction (ED). The multi-center study conducted in Korea 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, 240 men with ED of broad etiology and severity were randomized to one of four treatment groups: Placebo, udenafil 25 mg, udenafil 50 mg or udenafil 75 mg. Patients took one tablet a day for 12 weeks with evaluations every 4 weeks. The primary efficacy endpoint was the change in the standard International Index of Erectile Function (IIEF) Erectile Function Domain (EF) score from baseline to final visit. The secondary efficacy endpoints were the change from the baseline in the mean vaginal penetration success rates and mean intercourse completion rates calculated from the Sexual Encounter Profile (SEP) questions 2 and 3. In addition a sub-group analysis was conducted to determine efficacy in the patients that had lower urinary tract symptoms associated with benign prostatic hyperplasia in addition to erectile dysfunction.

The primary efficacy endpoint for the 50 mg and 75 mg doses were statistically significant compared to placebo. The mean vaginal penetration success rates at 12 weeks (final visit) were 98.7% (75mg) and 90.3% (50mg) and both dose levels were statistically significant compared to placebo (p<0.01). The change from baseline to final visit in the mean intercourse completion rates were 73.5% (75mg) and 51.4% (50mg) significantly (p<0.0001) higher compared to the 23.5% observed in the placebo group. Patients reporting improved erections after the 12-week course of therapy were 88% (75mg), 75% (50mg) and
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SOURCE Dong-A PharmTech Co. Ltd.
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