Progenics, Wyeth test intravenous methylnaltrexone in phase 3 trial

By Elaine Rigoli

Tampa, Fla., Sept. 20 - Progenics Pharmaceuticals, Inc. has started the first of two phase 3 clinical trials to evaluate the safety and efficacy of intravenous methylnaltrexone for the treatment of post-operative ileus, a debilitating impairment of the gastrointestinal tract that occurs after surgery, with Wyeth Pharmaceuticals, a Madison, N.J.-based pharmaceutical company.

There are no medicines currently approved to treat post-operative ileus, according to a Progenics news release.

Progenics, a Tarrytown, N.Y.-based biopharmaceutical company, said the first phase 3 study will enroll roughly 500 patients who have undergone segmental colectomy surgery in a double-blind, randomized, placebo-controlled clinical trial at approximately 90 surgical centers worldwide. Each patient will receive methylnaltrexone at one of two dose levels or a placebo following surgery and every six hours until the patient recovers gastrointestinal function or for up to 10 days.

The primary efficacy endpoint is duration of post-operative ileus as measured by time to first bowel movement. The study will also examine safety and other secondary measures of gastrointestinal recovery, including time to discharge eligibility.

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