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MoxDuo(TM) IR Demonstrates Fewer Side Effects Than Percocet(R)
Date:8/26/2009

ocet(R), which contains an opioid (oxycodone) combined with acetaminophen (like Tylenol(R)) have been the subject of recent FDA scrutiny due to their potential for causing significant adverse effects on liver and gastrointestinal function.

To date, more than 400 patients in six clinical trials have received MoxDuo IR for different forms of post-surgical pain (bunionectomy and total knee replacement). Study results with MoxDuo(TM) IR consistently demonstrate fewer side effects than observed with morphine alone, oxycodone alone and now with Percocet(R).

In this open label trial, each group of patients who experienced moderate to severe post-operative pain following total knee replacement surgery were treated every four to six hours over a 48-hour period. The study enrolled a total of 44 patients at five US clinical research sites.

All primary study objectives were met comparing: (1) the analgesic efficacy and safety profile of MoxDuo(TM) IR against control groups of patients receiving Percocet(R), a frequently used opioid for the treatment of pain; and (2) a flexible dosing regimen of MoxDuo(TM) IR against a fixed low dose (3/2mg). Patients receiving the flexible dosing regimen of MoxDuo(TM) IR achieved significantly greater pain relief than those receiving the low dose formulation (p<0.05).

Data collected from this study provide additional guidance for optimising the design and implementation of pending pivotal Phase 3 studies as the Company prepares for New Drug Application (NDA) filings with the US Food and Drug Administration (FDA) in 2010.

MoxDuo(TM) IR, the Company's lead product candidate, is part of a larger Dual-Opioid portfolio including intravenous (MoxDuo(TM) IV) and controlled release (MoxDuo(TM) CR) formulations. These formulations are designed to incorporate tamper resistance and reduced abuse liability as appropriate.

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SOURCE QRxPharma Limited
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