QRxPharma has announced the results of a Phase I trial for MoxDuo CR, a controlled-release Dual-Opioid designed to provide 12 hours of pain relief in patients suffering from moderate to severe chronic pain (including cancer, lower back, osteoarthritis and neuropathic). The purpose of the trial was to determine which of the various experimental formulations provided the optimum duration of drug levels in the blood.
The Phase I trial compared the rate at which key components of the CR formulation were absorbed, distributed, metabolized and eliminated by the body to the pharmacokinetic profile of Oxycontin 20 mg (sustained release oxycodone).
"We are now one step closer to addressing the needs of chronic pain patients and entering the multi-billion dollar chronic pain market," says QRxPharma CEO John Holaday. "QRxPharma remains on track to finalizing the MoxDuo CR tablet by the end of this year and to be in a position to initiate Phase II trials shortly thereafter."
According to the company, pharmacokinetic results are encouraging, and the profile is consistent with expectations for a twice-daily formulation. Data from the study will significantly aid QRxPharma and its manufacturing partner, Patheon, in finalizing the target release profile for the product and the composition of prototype MoxDuo CR tablets.
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