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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/naloxone combination can reduce patients' risk of developing opioid-induced constipation whilst providing comparable pain relief to the highly effective oxycodone - this new approach to opioid-based pain management therapy may be of potential benefit to a large number of patients suffering from chronic pain and will address an important unmet clinical need."

Oxycodone is a strong opioid analgesic, used for the treatment of severe chronic pain. Its efficacy has been demonstrated across a broad spectrum of pain states such as somatic and neuropathic pain(5,6). Recent experimental data in healthy volunteers and patients with chronic pancreatitis also suggest that oxycodone may be useful for the treatment of severe visceral pain(7,8).

Naloxone is an opioid receptor antagonist that is used intravenously to reverse opioid overdose. Oral naloxone has negligible systemic bioavailability, which means it provides a full, local inhibitory effect on opioid receptors in the gut, thus reducing the impact of opioid-induced constipation, while having no effect on the analgesic efficacy of oxycodone and minimal central effects.

The oral PR oxycodone / naloxone combination tablet has been licensed in Germany under the trade name TARGIN(R) for adult patients with severe chronic pain and will be submitted for registration in other European countries.

Notes to Editors:

- TARGIN(R) is a Registered Trademark.

About Mundipharma International Limited

Mundipharma International Limited is one of the Purdue/Mundipharma/Napp independent associated companies - privately owned companies and joint ventures covering the world's pharmaceutical markets. The companies worldwide are dedicated to bringing to patients with severe and debilitating diseases the benefits of novel treatment options in fields such as severe pain, haemato-oncology and respiratory disease. For more information: http://www.mundipharma.co.uk

About oxycodone

Oxycodone is a full opioid agonist with affinity for mu (micro) and kappa (k) receptors. Its opioid agonist actions are similar to those of other opioid analgesics, primarily affecting the central nervous system and smooth muscle. It is used, in both prolonged-release and immediate-release formulations, across a broad spectrum of moderate to severe cancer and severe non-cancer related pain types such as somatic (e.g. osteoarthritis), neuropathic (e.g. diabetic neuropathy) and visceral (e.g. pancreatitis) pain. As with all pure opioid agonists, there is no ceiling effect to the analgesia seen with oxycodone.

References:

(1) Muller-Lissner S et al. Oral prolonged release oxycodone / naloxone combination reduces opioid-induced bowel dysfunction in patients with severe chronic pain, presented at the World Institute of Pain Congress, Budapest (Presented on 26.09.07, Poster 1134)

(2) Coluzzi, F et al. Minverva Anestesiol 2005; 71: 451-460

(3) Thorpe DM et al. Curr Pain headache Rep 2001; 5: 237-240

(4) De Schepper HU et al. Neurogastroenterol Motil 2004; 16: 383-394,5

(5) Gimbel JS et al. Neurology 2003; 60: 927-934

(6) Watson CP et al. Neurology 1998; 50 : 1837-1841

(7) Staahl C et al. Differential effect of opioids in patients with chronic pancreatitis: An experimental pain study. Scandinavian Journal of Gastroenterology 2007;42; (3)

(8) Staahl C et al. A comparative study of oxycodone and morphine in a multi-modal, tissue-differentiated experimental pain model. Pain 2006; 123:28-36

For further information, please contact:

Aoife Gallagher

Tel: +44-(0)20-7331-2324

Fax: +44-(0)20-7331-9084

Email: aoife_gallagher@uk.cohnwolfe.com


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