Dong-A Pharma Announces Positive Results From ED Study

Dong-A PharmTech announced it has completed a 340-patient, Phase IIb clinical study for udenafil, its new long-acting oral phosphodiesterase type 5 (PDE5) inhibitor for treating erectile dysfunction (ED).

The multicenter 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 four-week non-drug baseline period, 340 men with ED were randomized to one of four treatment groups: placebo, udenafil 50 mg, udenafil 100 mg or udenafil 150 mg. The drug treatment period was 12 weeks with evaluations every four 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. The study had several secondary efficacy measurements including changes in scores from the other IIEF domains, changes from baseline in the Patient Self-Assessment Questionnaire and the mean Global Assessment Score.

All primary efficacy endpoints were statistically significant compared with placebo. Fifty percent of the patients in the 150-mg group shifted to normal erectile function (EF domain scores of greater than 25) after 12 weeks on the drug, compared with 14 percent in the placebo group. All three active dose levels were well tolerated. The most frequently reported adverse events were nasal congestion, flushing and headache and were mostly mild to moderate in intensity.

The company believes that the completion of the Phase IIb trial will allow it to proceed with Phase II clinical trials in the U.S. and Europe.

Udenafil was approved by the Korean FDA in November 2005 and launched by Dong-A in Korea under the brand name Zydena.