|Title||Result of Phase Ⅰ clinical trial of Tamsulosin 0.4mg GLARS achieves the goal|
GL PharmTech(CEO, Hun Sik Wang) drew an attention from pharmaceutical industry as the company announced that the result of Phase Ⅰ clinical trial of GL2702 Tamsulosin 0.4mg GLARS for benign prostatic hyperplasia has achieved the study goal.
This Phase Ⅰ clinical study aimed to assess the pk profiles, safety, and tolerability of GL2702 Tab., a high-dose IMD(incrementally modified drug) for Tamsulosin HCl vs. Harnal-D Tab® commercially available in the Korean market and Omix OCAS Tab® commercially available in the European market in healthy male adults.
" GLARS (Geometrically Long Absorption Regulated System) was designed to have triple-layered film, characterized by continuous efficacy maintenance during day and night by inducing additional drug absorption in the large intestine and by increasing late blood concentration compared to the conventional CR (controlled-release) drug." CEO, Mr. Wang said.
"Tamsulosin 0.4mg GLARS is a drug with novel biological profiles rather than that with dose that doubles that of the conventional drug, Harnal-D Tab® 0.2mg (Astellas Pharma)."
"As the expected pk profiles were obtained in this Phase Ⅰ study which compared the IMD with Harnal-D Tab® and Omix OCAS Tab®, we will discuss with the KFDA about the next clinical study" he added.
The domestic sales revenue of Tamsulosin HCl 0.2mg, which is the best selling drug of therapeutic agents for benign prostatic hyperplasia, was roughly 71.5 billion won in 2010. If GL2702 Tamsulosin HCl 0.4mg GLARS is released into the market, it is expected to have considerable competitiveness as no high-dose drug is currently available in the market.
GL PharmTech emphasized that the company is also preparing for technology licensing of GL2702 Tamsulosin 0.4mg GLARS to EU.