QRxPharma Successfully Completes Comparative Phase 1 Proof-of-Concept Study for MoxDuo(R) CR Tablet Formulation
Data Indicates Novel Sustained Release Pharmacokinetic Profile for Controlled-Release Formulation
PR Newswire
BEDMINSTER, N.J. and SYDNEY, May 10
BEDMINSTER, N.J. and SYDNEY, May 10 /PRNewswire/ -- QRxPharma (ASX: QRX and OTCQX: QRXPY) announced today the successful outcome of a Phase 1 trial for MoxDuo CR, a controlled-release (CR) Dual-Opioid(TM) 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 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,” said Dr. John Holaday, Managing Director and Chief Executive Officer, QRxPharma. “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.”
The Phase 1 trial, a single dose crossover design, was conducted in 14 normal healthy volunteers at one U.S. 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® 20 mg (sustained release oxycodone).
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 Inc., in finalising the target release profile for the product and finalising the composition of prototype MoxDuo CR tablets.
The Company’s MoxDuo® product portfolio includes both immediate and controlled release, as well as intravenous formulations. “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,” added Holaday.
SOURCE QRxPharma
