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QRxPharma Initiates Second Comparative Study for MoxDuo(TM) IR Dual-Opioid(TM) Pain Therapy
Date:2/19/2009

eplacement will be treated every four to six hours over a 48-hour period. The study is targeted to enroll a total of 45 patients at three US clinical research sites.

Primary objectives of the study include: (1) comparing 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) comparing MoxDuo(TM) IR against the present standard use of intravenous (IV) morphine in patients who self-control their pain relief using "patient controlled analgesia" (PCA). Data from these studies will further augment our knowledge about how to optimize the design and implementation of our pending pivotal Phase 3 studies in this patient population.

MoxDuo(TM) IR is the first patented analgesic product in the world that consists of two opioid drugs (a fixed ratio of morphine and oxycodone). While many analgesic combination drugs exist - such as Percocet(R) , which contains an opioid (oxycodone) combined with acetaminophen (like Tylenol(R)), such products are typically used for controlling mild to moderate pain. MoxDuo(TM) IR, however, is intended for the treatment of moderate to severe pain such as the acute pain that follows surgery. In six clinical trials conducted to date, data indicate that QRxPharma's patented combination of morphine plus oxycodone works synergistically to increase analgesia while diminishing the usual side effects of opioids. MoxDuo(TM) IR leads our development of a portfolio of dual-opioids(TM), including intravenous (MoxDuo(TM) IV) and sustained release (MoxDuo(TM) CR) formulations.

Based on the Company's July 2008 FDA meeting, final Phase 3 studies for MoxDuo(TM) IR will include a "combination rule" trial in patients experiencing post-surgery (bunionectomy) pain that compares MoxDuo(TM) IR against morphine alone and oxycodone alone, and a placebo-controlled study of the effectiveness of
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SOURCE QRxPharma Limited
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