The companies are seeking approval for Relistor in Europe for the treatment of opioid-induced constipation in advanced-illness patients who are receiving palliative care when response to usual laxative therapy has not been sufficient.
The Committee for Medicinal Products for Human Use (CHMP) is responsible for reviewing medicinal product applications for safety, quality and efficacy. The CHMP’s positive opinion will now be forwarded to the European Commission for a final decision, which is anticipated by mid-2008.