QRxPharma initiates Phase 1 trial for evaluating PK profiles of morphine, oxycodone CR formulations

Pilot Study to Evaluate Pharmacokinetic Profile of Experimental Formulations

QRxPharma (ASX: QRX and OTCQX:  QRXPY) announced today initiation of the Company's first Phase 1 trial to evaluate the pharmacokinetic (PK) profiles of experimental controlled-release (CR) morphine and oxycodone formulations that will be incorporated into MoxDuo®CR.  MoxDuo®CR contains a fixed 3:2 morphine:oxycodone combination and is intended to be dosed twice daily in patients experiencing chronic pain, an approximately US$7 billion dollar market worldwide.

In accordance with the recently approved IND filed with the US Food and Drug Administration (FDA), this two-part pilot study will compare the rate at which key components of the controlled-release formulation are absorbed, distributed, metabolized and eliminated by the body to the pharmacokinetic profiles of co-administered MS Contin® 30 mg (sustained release morphine) and Oxycontin® 20 mg (sustained release oxycodone).  The purpose of the study is to determine which of the various experimental formulations provide the optimum duration of drug levels in the blood for incorporation into MoxDuo®CR tablets.

"We are pleased to announce this Phase 1 study as it represents a significant milestone for the Company and the advancement of MoxDuo®CR to address the multi-billion dollar chronic pain market," said Dr. John Holaday, Managing Director and Chief Executive Officer, QRxPharma.  "With the initiation of this trial, all three MoxDuo® product presentations are now in the clinic and progressing toward commercialization."

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.  

QRxPharma's most advanced product, MoxDuo®IR, is now in pivotal Phase 3 studies and scheduled for New Drug Application (NDA) filing with the FDA in Q4 2010. MoxDuo®CR is expected to deliver clinical benefits similar to those demonstrated with the Company's immediate release formulation – fewer side effects with equal or better pain relief.

This Study is an open-label, single-dose, crossover trial in normal volunteers at one US clinical research site.  Study objectives are to:  (1) estimate the relative bioavailabilities for each experimental formulation using co-administered sustained release opioids as reference treatments; (2) to select the QRxPharma controlled-release formulation components that best match the PK profile targeted for each compound for incorporation into the MoxDuo®CR tablet; and (3) facilitate design of pivotal PK studies necessary for developing the final MoxDuo®CR tablet.

"Ultimately, our vision for the MoxDuo®CR tablet is to provide 12 hours of relief in patients with moderate to severe chronic pain including cancer, lower back, osteoarthritis, and neuropathic pain.  This proprietary formulation, manufactured with Patheon, will not only encompass sustained delivery technology (twice daily dosage), but also abuse deterrent and tamper resistant features," added Holaday.

SOURCE QRxPharma

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