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QRxPharma Releases Additional Phase 3 Data for Q8003IR 'Dual Opioid' Pain Therapy
Date:5/22/2008

Establishes Preferred Dose for Optimal Efficacy and Tolerability; Study Goals and Secondary Endpoints Met

SYDNEY, Australia and BEDMINSTER, N.J., May 22 /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 additional Phase 3 data for Q8003IR establishing a 12mg/8mg morphine and oxycodone combination as the preferred dose for optimal efficacy and tolerability.

"While the initial Phase 3 efficacy data demonstrated statistically significant pain reduction activity of Q8003IR at all dose levels, further analysis suggests that the 12mg/8mg dose delivers the best analgesic effect and tolerability profile," said Dr. John Holaday, Managing Director and Chief Executive Officer, QRxPharma. "These data confirm that our patented dual opioid combination of morphine and oxycodone provides synergistic effects on pain relief and is able to achieve equal or better analgesia at materially lower doses than the active opioid comparator while simultaneously reducing incidence levels of specific side effects."

The goal of the double-blind, placebo-controlled Phase 3 study was to compare four different dosage regimens of Q8003IR in patients with moderate to severe post-surgery pain (bunionectomy) and establish the preferred dose parameters. Secondary endpoints included: (1) efficacy relating to the time to onset of analgesia and the duration of effect from a single oral dose and (2) safety as measured by the incidence and intensity of opioid-related adverse events.

Of the patients receiving 12mg/8mg dose of morphine/oxycodone, 58% reported good to excellent global improvement (as compared to 13% for placebo) and demonstrated the greatest dose-response effect (p<0.0003) in terms of reducing pain intensity scores as well as other measures of analgesic effect.

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