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QRxPharma Successfully Completes Phase 1 Studies for MoxDuo® CR
Date:4/10/2012

BEDMINSTER, N.J. and SYDNEY, April 10, 2012 /PRNewswire/ -- QRxPharma (ASX: QRX and OTCQX: QRXPY) announced today successful completion of two Phase 1 studies in healthy volunteers for MoxDuo® CR, a controlled-release Dual-Opioid® utilising a 3:2 ratio of morphine and oxycodone. The proprietary MoxDuo CR formulation, encompassing both sustained delivery technology as well as abuse deterrent and tamper resistant features, is designed to provide at least 12 hours of analgesia in patients suffering from moderate to severe chronic pain including cancer, lower back, osteoarthritis and neuropathic pain. The clinical trials compared blood levels of MoxDuo CR's components to OxyContin® and MS Contin® and demonstrated MoxDuo CR's superior results, with sustained blood levels for up to 24 hours. Further studies indicated MoxDuo CR's increased resistance to tampering.

"The successful completion of these trials confirms the advantages of this formulation and enables QRxPharma to initiate Phase 2 Proof-of-Concept clinical studies mid-year 2012," said Dr. John Holaday, Managing Director and Chief Executive Officer of QRxPharma. "These data suggest MoxDuo CR may be positioned as a once or twice per day formulation for treating chronic pain, with the potential advantage of significantly reduced side effects as witnessed with immediate release MoxDuo. In the US alone, the chronic opioid pain market is a $6 billion a year opportunity."

Two Phase 1 trials were conducted in healthy volunteers to evaluate the rate at which key components of the MoxDuo controlled-release (CR) formulation were absorbed, distributed, metabolised and eliminated by the body. The first study compared MoxDuo CR (30mg morphine SO4/20mg oxycodone HCl) to the pharmacokinetic profiles of the same doses of MS Contin (30mg morphine SO4) and OxyContin (20 mg oxycodone HCl) in 10 healthy adult human subjects using a three-way crossover design. Pharmacokinetic results from the measu
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