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Relistor approved in the EU

The European Medicines Agency has given Wyeth Pharmaceuticals approval to market its subcutaneous injection
The European Medicines Agency (EMEA) has given Wyeth Pharmaceuticals approval to market its subcutaneous injection, Relistor, which has been developed for the treatment of opioid-induced constipation (OIC).

It is indicated for use in patients with advanced illness who are receiving palliative care and have not responded to the usual laxative therapy. The drug is now approved for use across all 27 EU member states as well as Iceland, Norway and Liechtenstein and is currently authorised for treatment of OIC in the US and Canada. A regulatory review of Relistor is also taking place in Australia.

Wyeth says that the OIC medication will be rolled out on a country-by-country basis, with the first launch expected to take place in the latter part of July 2008.

"We look forward to launching Relistor throughout Europe," said Steve Knezevic, chief medical officer EMEA for Wyeth Europa. "Both patients with advanced illness and their physicians will have the option of an innovative first-in-class treatment which finally targets the underlying cause of OIC."

Wyeth says that an ageing European population means there are more people living with advanced illness requiring palliative care. Opioids are routinely used for pain relief and resulting OIC is a near universal occurrence in patients being given this kind of treatment. Relistor works by reversing the slowing effects of opioids on the gastrointestinal tract and bowel without reducing their pain relieving effects.

Professor Lukas Radbruch, head of department for palliative care, University Hospital Aachen in Germany, and president of the European Association of Palliative Care, said: "It is so important that there are treatments available that target the underlying mechanisms of OIC, allowing pain to be managed while preserving quality of life in these patients."

7th July 2008

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