SAN FRANCISCO, May 10 /PRNewswire/ -- Dong-A PharmTech Co., Ltd. announced today that they presented clinical results on DA-8159, a new erectile dysfunction drug at the 99th Annual Meeting of the American Urological Association (AUA), May 8-13, 2004, at the Moscone Convention Center, San Francisco, California.
Data from a phase 1 pharmacokinetic and safety study on DA-8159, a novel oral medication in development for erectile dysfunction, was presented by Dr. Harin Padma-Nathan, Keck School of Medicine of the University of Southern California. The pharmacokinetic and safety study conducted in healthy Caucasian subjects shows that this highly selective phosphodiesterase type 5 inhibitor has a Tmax of 1.0-1.5 hours and a half-life of 11-13 hours. This unique pharmacokinetic profile suggests that DA8159 could have a relatively rapid onset and sufficiently long duration to make it effective for 24 hours. Prior studies have demonstrated a selectivity profile for DA-8159 that is similar to sildenafil but unlike tadalafil it does not inhibit PDE11 and thus would not be expected to produce significant myalgia.
The study evaluated ascending single and multiple oral doses of DA-8159, in a double-blind, placebo controlled phase 1 study. Ascending single doses of 50, 100, 200 and 400mg and multiple doses of 100 and 200mg (for 10 consecutive days) were administered. Adverse events, vital signs, 12-lead ECG, clinical laboratory tests, physical examination and pharmacokinetic profile were assessed.
The data indicates that DA-8159 was well tolerated in healthy Caucasians after a single oral dose up to 400 mg and 10-day repeated dose up to 200mg with a relatively low incidence of side effects. The most frequently reported side effects were spontaneous erections and headaches. No serious or severe side effects were reported.
In addition, a recently completed large Phase 2 clinical study indicated that DA-8159 may be efficacious across a broad population of ED patients. Data from this 282-patient phase 2 efficacy and safety study will be presented later this year.
The company plans to continue its worldwide development program for DA- 8159 by filing an IND in the USA and initiating USA clinical studies this year.
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.
Ms. Eun-Ju Jang
Manager, International Product Development
252, Yongdu-Dong, Dongdaemun-Ku
Seoul 130-078, Korea
Tel: +82 2 920 8212
Fax: +82 2 925 4026
Dong-A PharmTech Co., Ltd.