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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

lgesia used throughout the treatment period; and (2) safety as measured by incidence and intensity of opioid-related adverse effects.

To date, more than 500 patients experiencing pain following different surgical procedures (bunionectomy and total knee replacement) as well as non-surgical patients with chronic pain have received MoxDuo™IR.  Study results consistently demonstrate MoxDuo™IR's greater overall tolerability allowing the doctors and patients to achieve as good or better pain relief with substantially fewer incidences of nausea, vomiting, constipation, dizziness, and hypotension.  For example, at equal analgesic doses the frequency of moderate to severe adverse events was 50% to 75% lower among patients on MoxDuo™IR than those receiving morphine, oxycodone or Percocet® (oxycodone plus acetaminophen).  

In December, 2009, QRxPharma announced the initiation of its first Pivotal Phase 3 (combination rule) study in bunionectomy patients to demonstrate that MoxDuo™IR provides superior analgesia compared to its component doses of morphine and oxycodone. According to the FDA, once these two pivotal studies are completed, no additional pharmacology, toxicology or long-term clinical safety studies will be required for regulatory submission and market approval. QRxPharma expects to complete its Phase 3 program in Q3 2010 and file its NDA for MoxDuo™IR by the end of year 2010.  

Forward Looking Statements

This release contains forward-looking statements.  Forward-looking statements are statements that are not historical facts; they include statements about our beliefs and expectations.  Any statement in this release that states our intentions, beliefs, expectations or predictions (and the assumptions underlying them) is a forward-looking statement.  These statements are based on plans, estimates and projections as they are curren
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SOURCE QRxPharma Limited
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