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QRxPharma Releases Additional Pivotal Phase 3 Combination Rule Study Data for MoxDuo(R)IR in Patients with Post-Surgical Pain
Date:5/4/2010

Data Demonstrate Dual-Opioid(TM) Provides Significantly Better Pain Relief Compared to Component Doses; Study Goals and Secondary Endpoints Met

BEDMINSTER, N.J. and SYDNEY, Australia, May 4 /PRNewswire/ -- QRxPharma (ASX: QRX and OTCQX: QRXPY) announced today the release of additional pivotal Phase 3 trial data for MoxDuo IR, an immediate-release Dual-Opioid pain therapy.  Required for New Drug Application (NDA) submission with the United States Food and Drug Administration (FDA), this "combination rule" study compared the efficacy and safety profiles of MoxDuo IR against component doses of morphine and oxycodone alone for the management of moderate to severe post-operative pain following bunionectomy surgery.  MoxDuo IR not only demonstrated statistically superior analgesic effect compared to component doses of morphine (p=0.01) and oxycodone (p=0.01) but, also, a favorable side effect profile despite delivering twice the opioid dose of its individual components. The trial enrolled 522 patients at 6 US clinical research sites. Primary and secondary endpoints were met.

"While the initial trial data demonstrated the superiority of MoxDuo IR in terms of analgesic effect, further analysis revealed equally important findings in terms of superior overall pain relief, reduced reliance on supplemental analgesia and strong tolerability," said Dr. John Holaday, Managing Director and Chief Executive Officer, QRxPharma.  "These findings are consistent with earlier comparative data and reinforce both the clinical benefit and commercial potential of MoxDuo IR – our lead Dual-Opioid product candidate."  

The primary endpoint for evaluating the efficacy of MoxDuo IR 12 mg/8 mg versus its milligram compon
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SOURCE QRxPharma
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