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QRxPharma Successfully Completes Comparative Study for Dual-Opioid(TM) Pain Therapy
Date:4/20/2009

Primary Endpoints Met; Data Demonstrate MoxDuo(TM) IR Provides Better Tolerability Than Morphine and Oxycodone Alone

SYDNEY, Australia and BEDMINSTER, N.J., April 20 /PRNewswire-FirstCall/ -- QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today the successful completion of a Phase 3 program pilot study comparing the efficacy and safety profile of MoxDuo(TM) IR against component doses of morphine and oxycodone. Results demonstrated that MoxDuo(TM) IR reduces pain significantly more than its component doses; further, when compared to equianalgesic doses of morphine and oxycodone, MoxDuo(TM) IR produced fewer and less intense side effects. These results confirm 12mg/8mg morphine plus oxycodone combination as the preferred dose for optimal efficacy and tolerability as well as provide sample size guidance for the upcoming Phase 3 Combination Rule study required for NDA submission in 2010.

"Having achieved statistical significance in measures of decreased pain intensity with MoxDuo(TM) IR compared to its component doses, this pilot study exceeded expectations. Completed ahead of schedule and on budget, trial data clearly demonstrated the clinical and commercial value of our patented Dual-Opioid(TM), with the potential to give patients greater tolerability than morphine or oxycodone alone," said Dr. John Holaday, Managing Director and Chief Executive Officer, QRxPharma. "From these data, we are confident that our upcoming Phase 3 Combination Rule study will prove successful."

In this randomized, double blind study of 197 patients at 6 US clinical research sites, MoxDuo(TM) IR was compared to morphine and oxycodone in managing acute pain during the first 24 hours following a scheduled surgical procedure (bunionectomy). When postoperative pain reached a measure of at least "4" (moderate pain, with 10 being the most severe) on the Numerical Pain Rating Scale, patients received either MoxDuo(TM) IR, morp
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SOURCE QRxPharma Limited
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