New Long Acting Drug For Erectile Dysfunction: Dong-A PharmTech’s Udenafil, Passed Phase 2b Clinical Trial
Udenafil was approved by the Korean FDA in November 2005 and launched by Dong-A Pharmaceutical in Korea under the brand name Zydena® in late December 2005 as the fourth entrant to the ED market.
The said trial was a double-blind, placebo controlled multi-center study conducted in the U.S. which evaluated the efficacy and safety of udenafil in patients with ED where all primary endpoints were found statistically significant compared to placebo. The three doses evaluated were all found to be well-tolerated without adverse effects.
Dong-A PharmTech Co., Ltd. – a Korean late-stage pharmaceutical company - hopes that the completion of this Phase 2b trial will allow them to proceed with phase 3 clinical trials in the U.S. and Europe.
Find more details of the clinical data from the press release.
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