FDA Approves Drug for Opioid-Induced Constipation

Relistor could help restore bowel function in patients requiring continuous morphine

FRIDAY, April 25 (HealthDay News) -- The U.S. Food & Drug Administration (FDA) announced this week that it has approved Relistor (methylnaltrexone bromide) to help restore bowel function in patients with late-stage, advanced illness requiring chronic opioids for pain control.

Patients with advanced illnesses, such as end-stage chronic obstructive pulmonary disease, heart failure, metastatic cancer and late-stage HIV/AIDS, are often prescribed opioids to help manage pain associated with their illnesses. However, opioids can also lead to constipation by causing relaxation of intestinal smooth muscle. Relistor acts by blocking opioid entrance into cells, thereby improving bowel function.

Two large randomized, placebo-controlled trials including 287 individuals with late-stage disease demonstrated that patients taking Relistor had significantly improved rates of elimination when compared with those receiving placebo. Commonly reported side effects of Relistor included abdominal pain, gas, nausea, dizziness and diarrhea. Relistor should not be used in patients with known or suspected bowel obstruction.

"This new drug will be helpful to patients who experience severe constipation associated with the continuous use of morphine or other opioids, which are an important part of care for patients with late-stage, advanced illness," said Joyce Korvick, M.D., the FDA's deputy director of the Division of Gastroenterology Products.

Relistor is manufactured by Wyeth Pharmaceuticals Inc. of Philadelphia and Progenics Pharmaceuticals of Tarrytown, N.Y.

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