Australian drug maker QRxPharma (ASX: QRX and OTCQX: QRXPY) has enlisted New Jersey-based contract manufacturer Patheon to manufacture clinical supplies of a controlled-release pain relief formulation, MoxDuo CR. The Dual-Opioid controlled-release candidate is intended to provide 12-hour relief to those suffering moderate to severe chronic pain from cancer, osteoarthritis and other causes.
"Our goal is to provide physicians and patients with complementary Dual Opioids for managing pain," says John Holaday, QRxPharma CEO, in an announcement.
Holaday says he expects Phase I studies for evaluation of pharmacokinetic profile to begin this year. The company's MoxDuo IR candidate is now in Phase III trials and scheduled for a New Drug Application filing next year. The product portfolio comprises immediate release, controlled release and intravenous formulations for use in hospitals and at home.
For U.S. distribution, the down under drug maker may be on the hook to develop a Risk Evaluation and Management Strategy (REMS) program, an increasingly called-for step by the FDA as part of the approval process for opioids. Such a step was required of Meda Pharmaceuticals recently in its launch of Onsolis, as reported earlier.
- here's the announcement
- see our Onsolis REMS coverage