SEOUL, Korea, March 23 /PRNewswire/ -- Dong-A PharmTech Co., Ltd. announced today that they have filed an IND in the USA and will commence clinical trials on their new phosphodiesterase type 5 (PDE5) inhibitor for erectile dysfunction. The clinical program in the USA will start during the second quarter of this year with a double-blind, placebo controlled, phase 2, dose confirmation study in approximately 300 patients. The study will evaluate ED patients of all severities in a 12 week at home study.
Dong-A PharmTech's new oral product (udenafil) for ED is in late stage clinical development in Korea. The phase 3 clinical trials in Korea have just completed and the company expects to file a NDA for marketing approval in Korea within a few months. As such, udenafil will be the 4th PDE5 inhibitor to be commercialized. Previous clinical studies in Korea, in approximately 300 patients, have shown that udenafil produced highly significant improvement in erectile function after 12 weeks of drug therapy with up to a 91% vaginal penetration success rate and up to 67% intercourse completion rate compared to 29% for the placebo group.
Additionally, 40% of the patients in the previous studies at the high dose level returned to normal function after 12 weeks on drug compared to only 9% on placebo. The overall patient satisfaction as measured by the standard global assessment question (GAQ) was up to 86% in the high dose treatment group compared to 26% in the placebo group. The most frequently noted side effects were mild to moderate facial flushing and headache which are expected for this class of drug.
Previous phase 1 studies conducted in both the United Kingdom and Korea have shown that udenafil has a unique pharmacokinetic profile (Tmax of 1.0-1.5 hours and a half-life of 11-13 hours) suggesting that it could have a relatively rapid onset and sufficiently long duration to make it effective for up to 24 hours. Prior studies have also demonstrated a selectivity profile for udenafil that is similar to sildenafil but unlike tadalafil it does not inhibit the PDE11 isozyme and thus would not be expected to produce significant myalgia.
Mr. Dong Hyun PARK, President & CEO of Dong-A PharmTech, stated, "Filing an IND and initiating our clinical program in the USA is a significant milestone for Dong-A PharmTech Co. Ltd. We are confident that the initial dose confirmation study in the USA will verify the excellent efficacy and safety results that we have seen in numerous non-USA trials."
About Dong-A PharmTech Co., Ltd.
Dong-A PharmTech Co., Ltd. is an affiliate of Dong-A Pharmaceutical Co., Ltd. which, founded in 1932, is the largest drug company in Korea. Dong-A PharmTech plans to oversee non-Korean development programs for this unique compound.
Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risk and uncertainties that may individually or mutually impact the matters herein described, including but not limited to FDA review and approval, product development and acceptance, manufacturing, competition, and/or other factors, which are outside the control of the Company.
Dong-A PharmTech Co., Ltd.
CONTACT: Ms. Eun-Ju Jang, Manager, International Product Development ofDong-A PharmTech Co., Ltd., +82 2 920 8212, or fax, +82 2 925 4026, email@example.com