|Title||GL PharmTech successfully completes Phase Ⅰ clinical trial of IMD for opioid analgesic, Oxycodone|
Once-daily IMD with modified usage and dosage of the conventional opioid analgesic
GL PharmTech (CEO, Hun Sik Wang) drew an attention from incrementally modified drug(IMD) development as the company has successfully completed Phase I clinical study of GL2907 Tab., IMD with modified usage and dosage of the conventional opioid analgesic, Oxycodone, submitting the report to the MFDS.
Two Phase Ⅰ clinical trials were conducted. One was a randomized, open-label, single-dose, cross-over study on clinical pharmacology and dietary influence, and the other was a study to compare pk profiles of GL2907 vs. Oxycontine CR 10mg Tab.(Mundipharma) via repeated administration in healthy male adults.
Oxycodone belongs to opioid analgesics (Morphine, Heroin, Codeine), and is a semisynthetic opioid analgesic that acts on the central nervous system. It has an analgesic effect by directly binding to opioid receptors. Due to low first-pass effect during oral administration, it has higher bioavailability and lower variation between species. Thus, it is effective in the control of intermediate and severe pain which requires treatment with opioid analgesics.
Compared to the conventional drug that is administered daily twice, GL2907 Tab., which was developed by GL PharmTech as an once-daily drug, has advantages of improving drug compliance, maximizing analgesic effect by constantly maintaining blood oxycodone concentration, and reducing the occurrence rate of adverse events due to stable profiles. Thus, GL2907 is expected to significantly improve the quality of life in patients who require ATC(Around-the-clock) pain control.
"When pk profiles were compared between GL2907 and the conventional twice-daily drug, Oxycontine CR Tab 10mg, the same bioequivalence was obtained for Cmax and AUC. Once the report of this trial is completed, we plan to file GL2907 Tab. 20mg approval for marketing this year. In addition, we will file IND for Phase Ⅰ clinical study of GL2907 40mg and 80 mg.” CEO Mr. Wang said.