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QRxPharma Initiates Second Pivotal Phase 3 Study of MoxDuo(TM)IR Dual-Opioid(TM) for NDA Submission
Date:2/10/2010

Evaluate Analgesic Efficacy and Safety of MoxDuo(TM)IR in Patients with Moderate to Severe Post-Operative Pain Following Total Knee Replacement Surgery

SYDNEY and BEDMINSTER, N.J., Feb. 10 /PRNewswire/ -- QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today initiation of its second pivotal Phase 3 registration trial (Study 009) to evaluate analgesic efficacy and safety of MoxDuo™IR, a patented 3:2 ratio fixed dose combination of morphine plus oxycodone.  This two-arm study will compare the effectiveness and safety of a flexible MoxDuo™IR dose regimen to a fixed low dose for managing moderate to severe pain in patients who have undergone total knee replacement surgery.  The Company expects to complete dosing in Q3 2010 in preparation for filing a New Drug Application (NDA) with the US Food and Drug Administration in Q4 2010. MoxDuo™IR targets the acute pain market, a $2.5 billion segment of over $7 billion spent annually on prescription opioids in the US.

"In support of our Phase 3 program, clinical trials conducted to date have consistently demonstrated MoxDuo™IR achieves as good or better pain relief with fewer incidences of moderate-severe side effects than morphine, oxycodone or Percocet®. Based on these data, we are optimistic about the competitive advantages of MoxDuo," said Dr. John Holaday, Managing Director and Chief Executive Officer, QRxPharma.  "With the initiation of the Company's second pivotal trial for MoxDuo™IR, we are one step closer to definitively proving the value of our Dual-Opioid™ product to potential partners, prescribers and patients."

In 2009, an open-label pilot study demonstrated improved analgesia of flex
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SOURCE QRxPharma Limited
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