U.S. Food and Drug Administration
QRxPharma Successfully Completes Pivotal Phase 3 Combination Rule
Published in Clinical Trials Week, April 26th, 2010
QRxPharma announced the successful completion of the first of two pivotal Phase 3 studies for MoxDuo=AEIR, an immediate-release Dual-Opioid™ pain therapy. Required for FDA New Drug Application (NDA) submission, this combination rule study -- comparing the efficacy and safety profiles of MoxDuo=AEIR against component doses of morphine and oxycodone alone -- demonstrated that MoxDuo=AEIR reduces moderate to severe pain following bunionectomy surgery significantly better than its individual components.
"The path to commercialization is clear. With the successful completion of this pivotal trial, we believe we have satisfied the FDA's 'combination rule' requirement...
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Source: Clinical Trials Week (2010-04-26)
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