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 1 trial, a single dose crossover design, was conducted in 14 normal healthy volunteers at one US clinical research site. This study compared the rate at which key components of the CR formulation were absorbed, distributed, metabolised and eliminated by the body to the pharmacokinetic profile of Oxycontin 20mg (sustained release oxycodone).
QrxPharma said that the pharmacokinetic results are encouraging, and the profile is consistent with expectations for a twice-daily formulation. Data from this study will significantly aid QRxPharma and its manufacturing partner, Patheon, in finalising the target release profile for the product and finalising the composition of prototype MoxDuo CR tablets.
John Holaday, managing director and CEO of QrxPharma, said: “The successful outcome of this trial reinforces QRxPharma’s intellectual property that defines MoxDuo CR as a novel, controlled-release formulation for sustained pain relief.
“We are now one step closer to addressing the needs of chronic pain patients and entering the multi-billion dollar chronic pain market. QRxPharma remains on track to finalising the MoxDuo CR tablet by the end of this year and to be in a position to initiate Phase 2 trials shortly thereafter.
“Our goal is to provide physicians and patients with a variety of complementary Dual-Opioids for managing moderate to severe pain from hospital to home.”