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QRxPharma Releases Successful Phase 3 Study Results for 'Dual Opioid' Pain Therapy
Date:5/5/2008

Q8003IR Met Primary Endpoints; Demonstrated Strong Reduction of Pain Intensity

SYDNEY, Australia and BEDMINSTER, N.J., May 5

/PRNewswire-FirstCall/ -- QRxPharma Limited (ASX: QRX), a clinical-stage specialty pharmaceutical company focused on the development and commercialisation of therapies for pain and central nervous system (CNS) disorders, announced today initial Phase 3 efficacy results for Q8003IR, an immediate release dual-opioid product intended for the acute management of moderate to severe pain.

"Initial Phase 3 efficacy data demonstrated statistically significant analgesic activity at all doses tested and reinforces the potential clinical benefit and commercial value of QRxPharma's lead dual-opioid product," said Dr. John Holaday, Managing Director and Chief Executive Officer, QRxPharma. "We are pleased with this study outcome and believe that it demonstrates that the Company remains on target to complete clinical testing for Q8003IR, submit a New Drug Application (NDA) in 2009 and achieve its goal of product launch in 2010."

The double-blind, placebo-controlled study was designed to compare the efficacy and safety of four different dosage regimens of Q8003IR, a fixed ratio morphine/oxycodone combination. 256 patients with moderate to severe pain following surgery (bunionectomy) completed the trial, and it was conducted at six US clinical research sites. The primary efficacy analysis compared the change in pain intensity scores over the 48 hr dosing period (SPID48) in patients receiving Q8003IR vs. placebo.

Among all patients receiving Q8003IR, approximately 50% reported good to excellent global improvement (vs. 13% for placebo) and demonstrated a strong dose-response effect (p<0.001) in reducing pain intensity scores [i.e. the sum of pain intensity difference over 48 hours relative to the first dose (SPID48)] and other measures of analgesic effect. Per treatment group, median doses received every 4 hours
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SOURCE QRxPharma
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