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QRxPharma Successfully Completes Phase 1 Studies for MoxDuo® CR
Date:4/10/2012

rement of opioid blood levels over time revealed a MoxDuo CR profile consistent with expectations for a once to twice-daily formulation.

The second study demonstrated that food consumption does not alter the pharmacokinetic profiles of morphine and oxycodone from MoxDuo CR (30 mg/20 mg) tablets using a two-way crossover design with 17 healthy volunteers. To demonstrate the effects of chronic use on steady-state blood levels, this study also measured the repetitive-dose pharmacokinetic profiles of morphine and its metabolites as well as oxycodone during repetitive (twice daily) administration of MoxDuo CR tablets for 5 days.

The MoxDuo CR tablets used in these clinical tests included QRxPharma's proprietary Abuse Deterrence Formulation (ADF) technology. As an indication of tamper resistance, attempts to extract morphine or oxycodone by crushing and solubilising in water or alcohol resulted in very limited (less than 15%) drug recovery. In addition, the ADF technology did not impair human bioavailability of the opioids following oral administration.

"Clinical performance of the oral MoxDuo CR formulation clearly exceeded our expectations. When directly compared to OxyContin, the largest selling opioid for chronic pain, MoxDuo CR demonstrated superior bioavailabilty and sustained blood levels for over 12 hours, especially in the 12-24 hour time period. At steady-state, MoxDuo CR provided very low fluctuations of oxycodone. MoxDuo CR appears to be a true once or twice a day delivery system for dual opioids," said Dr. Ed Rudnic, Chief Operating Officer, QRxPharma. "We expect that MoxDuo CR's sustained blood levels, ADF attributes and potential side effect benefits will enhance the tolerability and acceptability of MoxDuo CR in the global chronic pain marketplace."

The CR formulation of MoxDuo encompasses the same 3:2 ratio of morphine and oxycodone as in MoxDuo IR, QRxPharma's immediate release acute pain formulation that is scheduled for PDUF
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SOURCE QRxPharma
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