|Title||GL PharmTech files IND for PhaseⅠclinical trial of opioid analgesics|
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IMD with modified usage and dosage of the conventional opioid analgesics
GL PharmTech(CEO, Hun Sik Wang) drew an attention from pharmaceutical industry as the company announced that the company has filed IND for phase Ⅰ clinical trial of GL2907, an IMD(incrementally modified drug) with modified usage and dosage of the conventional cancer pain control drug, Oxycodone.
A typical drug containing oxycodone is Oxycontin CR (controlled-release) Tab.(Mundipharma), which is administered daily twice. Its annual domestic sales revenue is about 10 billion won.
In particular, Mundipharma defeated ‘Ocodone CR Tab.’, first generic of ‘Oxycontin CR’, in an invalid patent litigation which was claimed by Hana Pharma that commercialized Ocodone CR Tab..Besides, in a civil action for damages, Hana pharma agreed to withdraw Ocodone CR Tab. from the market according to the court ruling adjustment order.
Accordingly, oxycodone-related lawsuit has been resolved, and the development of IMD for oxycodone by GL PharmTech draws more attention from the relevant industry.
GL2907, which was developed by GL PharmTech as an IMD for oxycodone, is an IR(immediate release) drug. It is administered daily once to reduce the inconvenience of the conventional twice-daily drug and to improve drug compliance.
This Phase Ⅰclinical trial is a randomized, open-label, single-dose, cross-over study to compare pk profiles of GL2907 vs. Oxycontin CR 10mg (Mundipharma) and to assess dietary influence. Its IND approval is expected to be received by January 2012, followed by study initiation in February 2012.
"The result of preclinical study of GL2907 showed the appropriate Cmax and AUC for once-daily administration without safety concern." GL PharmTech said.
"The devolvement of once-daily IMD is expected to maximize drug compliance and to improve the quality of life in patients who require "Around-The-Clock" pain management by maintaining constant blood oxycodone concentration." GL PharmTech emphasized.