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New Phase III Data Demonstrate Oxycodone / Naloxone Combination Tablet Reduces Opioid-Induced Bowel Dysfunction in Patients With Chronic Severe Pain
Date:9/26/2007

New Approach in the Development of Opioid-Based Pain Management Therapy

Improves Bowel Function

CAMBRIDGE, England, September 26 /PRNewswire/ -- The oral prolonged-release (PR) oxycodone / naloxone combination tablet reduces opioid-induced bowel dysfunction in patients with chronic severe pain compared to treatment with oxycodone alone, according to new data presented today at the World Institute of Pain (WIP) Congress, Budapest(1).

A Phase III trial of 463 patients was designed to evaluate the symptoms of constipation of the oral PR oxycodone / naloxone combination tablet compared to PR oxycodone tablets. The results show that the combination of the opioid receptor agonist naloxone and the opioid analgesic oxycodone is associated with a reduction in the impact of opioid-induced bowel dysfunction - a class effect associated with all opioids - compared to treatment with oxycodone alone or placebo. The data also demonstrate that use of laxatives was reduced by treatment with the combination tablet.

Today's study suggests that oral PR oxycodone / naloxone combination treatment may allow patients suffering from chronic severe pain to receive effective pain relief whilst reducing the risk of opioid-induced bowel dysfunction.

Opioids are amongst the most widely used analgesics for the treatment of patients with severe chronic pain; however, although highly effective, the use of these treatments long-term is associated with the development of bowel dysfunction. Opioid-induced bowel dysfunction encompasses a number of symptoms; of these, constipation is the most frequently reported adverse effect in patients who receive chronic opioid therapy(2,3). In some cases, opioid-induced constipation can be so severe that patients opt to discontinue therapy(4).

Professor Stefan Muller-Lissner, Department of Internal Medicine, Humboldt University, Berlin, commented, "Today's data suggest that the new oral PR oxycodone/nal
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SOURCE Mundipharma International Ltd
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