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

Cambridge, England (ots/PRNewswire) -

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

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

ots Originaltext: Mundipharma
Im Internet recherchierbar: http://www.presseportal.de

Contact:
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