Mundipharma Submits New Analgesic Targin (Prolonged Release Oxycodone / Naloxone Combination) For European Approval

Main Category: Pain / Anesthetics
Also Included In: Regulatory Affairs / Drug Approvals;  Back Pain
Article Date: 11 Jul 2008 - 3:00 PDT

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Mundipharma announced that Targin, an oral prolonged-release oxycodone / naloxone combination tablet, has been submitted for regulatory approval in Europe.

Targin is a combination of a strong opioid receptor agonist, oxycodone, and a locally acting opioid receptor antagonist, naloxone. The oxycodone provides the analgesic effect, while the naloxone, exerting its effect only in the gut (before being eliminated by the liver), prevents the onset of opioid-induced constipation (OIC) through blockade of the opioid receptors found in the gut.

Targin was granted marketing authorisation approval in Germany in May 2006 on the condition that further trial data was provided. It is indicated there for the treatment of moderate to severe pain with the naloxone component indicated for therapy and/or prophylaxis of opioid induced constipation. The data has now been provided enabling Targin to proceed for European regulatory approvals with Germany acting as the reference member state.

The regulatory submission for Targin® is based on a comprehensive clinical trial programme which demonstrated that patients treated with Targin® benefit from equally strong analgesic efficacy as oxycodone alone, and experience a reduction in the impact of OIC compared to those treated with oxycodone.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 OIC.In some cases, OIC can be so severe that patients opt to discontinue therapy.

"We are pleased to report this significant milestone for Targin® and to submit a product for European regulatory review which has already gathered almost two years of real life clinical experience," commented Dr Karen Reimer, Mundipharma's European R&D Director.

1 in 5 European adults suffers from long-term moderate to severe chronic pain, often caused by osteo-arthritis or back pain.

About Targin®

Targin® is a combination of the strong opioid analgesic oxycodone and the opioid receptor antagonist naloxone in prolonged release formulation.

Oxycodone is a strong opioid analgesic, used for the treatment of severe chronic pain. Its efficacy has been demonstrated across a broad spectrum of severe pain states such as somatic and neuropathic pain. 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.

Naloxone is an opioid receptor antagonist that, when taken orally, has negligible systemic bioavailability, providing a full inhibitory effect on local opioid receptors in the gut - reducing opioid-induced constipation - without impacting on the centrally acting analgesic efficacy of oxycodone.

Targin® has been clinically proven to provide comparable analgesic efficacy to that of oxycodone, whilst significantly reducing or preventing OIC, a class effect associated with all opioids. Targin® is a prolonged-release formulation providing twice-daily dosing.

Targin® has been submitted to European authorities via European Regulatory Procedures for review, in 5/2.5, 10/5mg, 20/10mg and 40/20mg doses BD, for the treatment of moderate to severe pain. European countries participating are: Austria, Belgium, Cyprus, Denmark, Finland, Iceland, Ireland, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, Spain, Sweden, the United Kingdom, the Czech Republic, France and Romania, in addition to the RMS, Germany.

*Targin® is a registered trademark.

About Mundipharma

The Mundipharma independent associated companies, including Mundipharma, Purdue and Napp, are 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. Targin® was developed by Mundipharma Research.

Mundipharma