Dong-A PharmTech Co., Ltd. and Dr. Falk Pharma GmbH Announce Positive Data in Portal Hypertension With Udenafil
SEOUL, South Korea, June 13, 2011 /PRNewswire/ — Dong-A PharmTech Co., Ltd. and Dr. Falk Pharma GmbH announced positive results from an initial safety and efficacy portal hypertension study in man using udenafil, its new long-active phosphodiesterase inhibitor. The data was presented by the principal investigator, Prof. Wolfgang Kreisel, Department of Gastroenterology, Hepatology, Endocrinology and Infectious Diseases, University of Freiburg, Freiburg, Germany.
In a 1-week open-label, multicenter phase 2 trial, 20 patients with portal hypertension (Child-Pugh A/B) that met the selection criteria were given a daily oral dose of one of four dose levels of udenafil. The primary efficacy endpoint was the change of hepatic venous pressure gradient (HVPG) from day 0 (pre dose) to day 6 post dose. A total of 7 of 20 patients showed a response defined as a HVPG reduction of < 12 mmHG or by > 20% after one week of daily dosing. In the high dose group, HVPG was lowered in 4 of the 5 patients by more than 10% after administration of study drug on day 0 or day 6. No decrease of mean arterial blood pressure was seen in any of the four dose groups. Standard liver biochemical tests did not change during the study and no adverse events were attributed to the study drug.
The results of this study show that the oral application of the new PDE-5 inhibitor udenafil lowers HVPG in an acute setting without any systemic cardiovascular side effects. Effectiveness appears to be dose related. Further study is contemplated using a placebo controlled design and a longer study duration.
About Dong-A PharmTech Co., Ltd.
Dong-A PharmTech is a late-stage pharmaceutical company incorporated in Korea, focused on the development and commercialization of udenafil worldwide excluding Korea.
About Dr. Falk Pharma GmbH .
Dr. Falk Pharma GmbH is one of the most recognized companies worldwide in gastroenterology. Dr. Falk Pharma products are sold in more than 60 countries. The Falk Foundation, which is associated with the Company, provides medical information via international symposia, forums and postgraduate courses. Over the past 50 years the Falk Foundation has sponsored more than 200 symposia in which over 100,000 physicians from 110 countries have come together to advance knowledge in gastroenterology and hepatology.
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.
Mr. Won Geun KIM
Tel: +82 2 560 8008
Fax: + 82 2 563 6517
SOURCE Dong-A PharmTech Co., Ltd.