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FDA approves drug to treat opioid-induced constipation
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The FDA has approved methylnaltrexone bromide subcutaneous injection for the treatment of opioid-induced constipation in patients receiving palliative care who do not benefit from laxatives.
“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,” Joyce Korvick, MD, deputy director of the Division of Gastroenterology Products at the FDA, said in a press release.
Methylnaltrexone bromide (Relistor, Wyeth-Progenics) displaces opioids from the mu-opioid receptors outside of the central nervous system to reduce constipation without interfering with pain relief. The opioid-medicated analgesic effects of the central nervous system are not compromised by the drug due to its chemical structure.
Evidence to support approval
Wyeth and Progenics sponsored two randomized, placebo-controlled trials to explore the safety and efficacy of the new drug in 287 patients over a four-month period. Patients in both trials had advanced late-stage illness with a life expectancy of less than six months.
During the week prior to treatment, patients had either less than three bowel movements or no bowel movement for more than two days. Compared with patients assigned to placebo, those assigned to methylnaltrexone bromide had a higher rate of elimination.
In the two phase-3 clinical trials, abdominal pain, flatulence and nausea were the most common adverse events associated with treatment. Wyeth and Progenics advised against using the drug in patients with gastrointestinal obstruction.
The FDA states that the drug can be administered as necessary, but one dose should not be exceeded in a 24-hour period. For patients with late-stage advanced illness, the FDA recommends one dose every other day as needed.
The new drug, which will be available in June, has not been studied in pediatric populations or for a period exceeding four months.