30 November 2009 - Australian clinical-stage specialty pharmaceutical company QRxPharma Limited (ASX: QRX) said today that, as part of its Phase III programme, it has started a registration trial (Study 008) to compare the efficacy and safety profiles of MoxDuoIR against component doses of morphine and oxycodone alone for the management of moderate to severe post-operative pain following bunionectomy surgery.

The company expects to complete dosing by close of second quarter 2010.

CEO Dr. John Holaday said that the company has recently reported clinical studies demonstrating the superiority of MoxDuoIR in terms of tolerability compared to equi-analgesic doses of morphine, oxycodone and Percocet for the management of acute post-operative pain. These studies demonstrated that MoxDuoIR provides significant pain relief and fewer side effects (nausea, vomiting, dizziness and constipation), added Holaday.

A double-blind study with about 35 patients per group, completed earlier this year in patients with pain following bunionectomy surgery, demonstrated the superiority of MoxDuo 12 mg/8 mg relative to 12 mg morphine and to 8 mg oxycodone. The purpose of the current Phase III registration study (008) is to replicate these differences in a larger trial, one with sufficient statistical power to achieve significance on the primary and secondary endpoints. If successful, this trial will satisfy the "Combination Rule" requirement of the US Food and Drug Administration (FDA) and will also serve as a registration study.

This double-blind, randomised and repeat fixed-dose study compares MoxDuoIR's reduction in pain intensity (primary endpoint) to component doses of oxycodone and morphine in patients experiencing moderate to severe post-operative pain over 48 hours. The study is targeted to enroll 522 patients (with 174 in each treatment group) at 6 US clinical research sites.

The primary endpoint for evaluating the efficacy of MoxDuoIR 12 mg/8 mg versus its milligram components of morphine 12 mg and oxycodone 8 mg administered every six hours is the difference in pain intensity scores for each patient group over the 48-hour treatment period (SPID48 calculated from the 10-point Numerical Pain Rating Scale). Secondary endpoints include efficacy relating the patient's global assessment of effect (i.e. extent of overall pain relief) as well as amount of supplemental analgesia (acetaminophen) used throughout the treatment period; and safety as measured by incidence and intensity of opioid-related adverse effects. QRxPharma incorporated input from the FDA regarding the design and statistical analysis of this study.

The company said that the final Phase III registration trial (Study 009: a double-blind controlled study to evaluate the effectiveness of MoxDuoIR in patients following total knee replacement surgery) is scheduled to begin in the first quarter of 2010. No additional pharmacology, toxicology or long-term clinical safety studies will be required for regulatory submission and market approval, added QRxPharma. The company expects to complete its Phase III programme in the third quarter of 2010 and file its NDA for MoxDuoIR by the end of 2010.

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