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Efficacy and Safety Study to Support Phase 3 Combination Rule Trial for NDA Submission
SYDNEY, Australia and BEDMINSTER, N.J., Dec. 15 /PRNewswire-FirstCall/ -- QRxPharma Limited (ASX: QRX and OTCQX: QRXPY), a clinical-stage specialty pharmaceutical company focused on the development and commercialization of therapies for pain and central nervous system (CNS) disorders, announced today initiation of a comparative study to evaluate the efficacy and safety profile of MoxDuoIR(TM) against equivalent analgesic doses of morphine and oxycodone alone for the treatment of acute moderate to severe pain. Data collected from this study will also be used to support final Phase 3 trials required for NDA submission. The Company expects to complete dosing prior to Q2 2009.
"While successful clinical trials to date have shown the potential of MoxDuo(TM) to provide equal or better analgesia with a reduction of total opioid dose and improved tolerability, this study is designed to provide direct evidence of enhanced efficacy when compared to equivalent analgesic doses of morphine and oxycodone alone," said Dr. John Holaday, Managing Director and Chief Executive Officer, QRxPharma. "Our goal is to demonstrate the clinical value and superiority of MoxDuoIR(TM) over its individual components in post-surgical acute pain relief."
The double-blind, randomized and repeated fixed-dose study compares MoxDuoIR's(TM) efficacy and safety to corresponding doses of oxycodone and morphine in patients experiencing moderate to severe pain following a scheduled surgical procedure (bunionectomy). The study is targeted to enroll 180 patients at 6 US clinical research sites.
The primary clinical endpoints for this study focus on pain relief and intensity scores of MoxDuoIR(TM) versus equivalent doses of morphine and oxycodone alone during the first 24 hours following surgery. Secondary endpoints include: (1) ef
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