Wyeth/Progenics initiate Ph III trial of POI treatment

Drug major Wyeth and fellow USA-based Progenics Pharmaceuticals have initiated the second of two global, pivotal Phase III clinical trials to evaluate the safety and efficacy of intravenous methylnaltrexone for the treatment of post-operative ileus. The first Phase III trial was initiated in September 2006.

POI is a temporary impairment of gastrointestinal function characterized by abdominal bloating and pain, nausea and vomiting, and an inability to pass gas or a stool and is a common response to abdominal surgical procedures, but can also occur after other types of surgery. However, POI can worsen when opioid analgesics are given to relieve post-operative pain, potentially leading to delayed introduction of food, lengthened hospital stays and increased health care costs.

The firms noted that methylnaltrexone is a mu-opioid receptor antagonist designed to reverse the peripheral side effects caused by opioids, particularly in the GI tract, that does not interfere with brain-centered pain relief. In a pilot Phase II clinical trial previously conducted by Progenics, patients who received methylnaltrexone following segmental colectomy exhibited improvements in clinically-important measures of GI recovery, including time-to-first bowel movement and hospital discharge eligibility.