|Title||GL PharmTech receives IND approval for Phase Ⅲ clinical trial of IMD for Tamsulosin|
Harnal-D®Tab (Astellas), the original drug containing Tamsulosin, had an annual sales revenue of 40 billion won in 2012according to the IMS. The total market of drugs containing Tamsulosin is estimated to reach 67.7 billion won.
GL2702 GLARS was developed by GL PharmTech as a high-dose Tamsulosin CR (controlled-release) Tab. containing Tamsulosin 0.4mg, which doubles that of the conventional drug containing 0.2mg Tamsulosin.
Upon the administration of the conventional Tamsulosin0.2mg, nocturia may occur as the drug concentration decreases at night, resulting in disrupting good sleep and reducing sleeping quantity and quality.
"GLARS (Geometrically Long Absorption Regulated System) was designed to have 3-layeredfilm, 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 drug." CEO, Mr. Wang said.
Tamsulosin 0.4mg GLARS is not a product with a dose that simply doubles that of the conventional brand, Harnal-D Tab. 0.2mg (Astellas Pharma), but a product with novel biological profiles.
Phase Ⅰ clinical study of GL2702 GLARS for assessing pk profiles was completed. IND filing for double-blind, multicenter, parallel, randomized, comparative phase Ⅲ clinical study has been approved to compare the efficacy and safety of GL2702 GLARS vs. Harnal-D® in benign prostatic hyperplasia patients with lower urinary tract symptom.
"Once the result of phase Ⅲ clinical trial is obtained, we will proceed marketing approval." CEO, Mr. Wang said.