Progenics reports methylnaltrexone shows benefits for opioid-induced constipation

New York, May 23 - Progenics Pharmaceuticals, Inc. and Wyeth Pharmaceuticals reported that a phase 3 clinical trial of methylnaltrexone helped patients with the treatment of opioid-induced constipation in patients with advanced illnesses, such as cancer and cardiovascular disease.

Nearly half of constipated patients with advanced illness experienced laxation (bowel movement) within four hours of receiving their first dose of methylnaltrexone (0.15 mg/kg), and more than 70% responded by the end of the first week of treatment (0.15 mg/kg qod).

For those who responded, the median time to laxation following methylnaltrexone treatment was 30 minutes, and there were no reports of diminished analgesia due to study medication.

The findings were presented at the Digestive Disease Week conference in Los Angeles Tuesday.

"In order to provide the most compassionate care possible, health care professionals want to focus on aggressive pain management without the worry of opioid-induced bowel dysfunction," said study investigator Neil Slatkin, director, department of supportive care, pain and palliative medicine, City of Hope, based in Duarte, Calif. "These data are encouraging for patients living with advanced illnesses who must take opioids to control their pain."

The trial was double blind and placebo controlled trial. It covered 133 patients with advanced illness at nursing homes, hospice and palliative care centers across the United States.

Patients received either methylnaltrexone (0.15 mg/kg, SC) or placebo every other day for two weeks. By day eight, a blinded dose escalation was permitted (methylnaltrexone, 0.30 mg/kg or placebo) if a patient did not have at least three bowel movements during the previous week that were not associated with rescue therapy. This dosing regimen was continued through the remaining week of the trial (dosing on days 9, 11 and 13). Co-primary endpoints were laxation within four hours of the first dose and laxations occurring within four hours of at least two of the first four doses.

Progenics is a biopharmaceutical company based in Tarrytown, N.Y. In December 2005, Wyeth and Progenics entered into a license and co-development agreement for the development and commercialization of methylnaltrexone.

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