|Title||GL PharmTech files IND for Phase Ⅰ clinical trial of once-daily Pregabalin|
Top 3 domestic pharmaceuticals are going to join the development consortium,
GL PharmTech (CEO, Hun Sik Wang) drew an attention from incrementally modified drug(IMD) development as the company has filed IND for phase Ⅰ clinical trial of GLA5PR, an IMD with modified usage and dosage of the conventional drug for neuropathic pain, Pregabalin. This is a fourth filing next to Kunwha pharma,Yuhan Co. Ltd., and CJ Healthcare that are developing Pregabalin CR (controlled-release).
The market invasion of Pregabalin (Lyrica Cap., Pfizer) is increasing with an annual sales revenue and growth of 44 billion won and 41%, respectively in 2011 according to the IMS.
GLA5PR was developed as an IR drug, which is administered once daily to reduce the inconvenience of the conventional pregabalin that is administered twice daily and to improve drug compliance.
Its pk profiles were already analyzed via a preclinical study. This IND filing aims to conduct phase Ⅰ clinical trials of two researches about pk study on single dose and dietary influence and pk study on multiple dose.
"GLA5PR is meaningful in the establishment of platform technology as it is a third project that uses the GLARS(Geometrically Long Absorption Regulated System), the company’s proprietary platform of CR. Pregabalin CR, which is currently being developed via Phase Ⅲ clinical study globally by Pfizer, has doses of 82.5mg, 165mg, and 330mg, which exceed 2-folds of those of the conventional twice-daily CR drug. Meanwhile, GLA5PR has doses of 150mg and 300mg that double those of the conventional twice-daily IR drug. Thus, technology licensing to other countries could be possible. In addition, top domestic pharmaceuticals including H, C, and D will join development consortium" CEO, Mr. Wang said.