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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

ible dose MoxDuo™IR (individual doses up to 24mg morphine/16mg oxycodone) compared to fixed, low dose MoxDuo™IR (3mg morphine/2mg oxycodone) in patients with moderate to severe pain following total knee replacement surgery. Based on these results, low dose MoxDuo™IR was selected as the control for this pivotal trial.

Study 009, a randomised, double blind trial, is targeted to enroll 140 patients (70 per study Arm) at 8 US clinical research sites.  Initially, all post-operative patients will receive intravenous patient controlled analgesia (PCA) morphine until the day following knee replacement surgery.  At such time, PCA morphine dosing will be stopped.  When pain becomes moderate to severe [based on the 10-point Numerical Pain Rating Scale (NPRS)], patients will then be randomised in equal numbers to receive either a flexible regimen of MoxDuo™IR (Arm 1) or the low dose control (Arm 2).

For patients assigned to the flexible dose regimen (Arm 1), the initial dose will be based on the Company's proprietary algorithm (developed in the prior open label study) that converts PCA morphine to oral morphine equivalents of MoxDuo™ IR.  All Arm 1 patients will start on at least 12mg/8mg (morphine/oxycodone); patients in Arm 2 will receive a loading dose of 6mg/4mg followed by 3mg/2mg regardless of their initial PCA dosing regimen. All patients will be dosed every four to six hours over a 48-hour period.  

The primary endpoint for evaluating the efficacy of flexible dose versus low dose is the difference from baseline in pain intensity scores for each treatment group over the 48-hour treatment period [Sum of Pain Intensity Differences over 48 hours (SPID(48)) calculated using the 10-point NPRS].  Secondary endpoints include:  (1) efficacy relating to the time to onset of analgesia and global assessment of effect (i.e. total pain relief) as well as amount of supplemental ana
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SOURCE QRxPharma Limited
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