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 .<
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