Methylnaltrexone enters trials for POI

USA-based firms Progenics Pharmaceuticals and Wyeth Pharmaceuticals, a division of Wyeth, say they have begun the first of two global Phase III trials designed to evaluate the safety and efficacy of intravenous methylnaltrexone for the treatment of post-operative ileus. The condition, for which there are no currently-approved medications, is a debilitating impairment of the gastrointestinal tract that is believed to be linked to the release of exogenous opioids in response to trauma during surgery.

The first Phase III study, which is designed to enroll 500 patients who have undergone a segmental colectomy operation, will assess the efficacy of methylnaltrexone, administered following surgery and thereafter every six hours until gastrointestinal tract function is recovered, or for a maximum of 10 days. The firms added that the primary efficacy endpoint is defined as the time to the first post-surgical bowel movement.

The companies also said that they intend to begin a second Phase III trial of the drug, which is under fast-track review by the Food and Drug Administration, in a similar post-surgical setting, later in the year. They added that, assuming the Phase III program is successfull, they intend to file a New Drug Application in late 2007 or early 2008.