FDA Approves Movantik for Opioid-induced Constipation

The new prescription medication words by unblocking receptors in the gut, allowing for return of normal bowel function.

Constipationopioid therapy.  When a person takes an opioid, the medication binds to receptors in the GI tract, reducing motility, making bowel movements difficult and causing patients to strain, have hard or lumpy stools or experience a sensation of incomplete evacuation.

Because Movantik is a mu opioid receptor antagonists, it decreases the constipating effects of opioids. “Supportive care products such as Movantik can lessen the constipating side effects of opioids,” said Julie Beitz, MD, director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research.

How it Was Approved

Movantik’s safety and effectiveness were established in two clinical trials of 1,352 participants who had taken opioids for at least 4 weeks  and had opioid-induced constipation. Participants were randomly assigned to receive 12.5 mg or 25 mg of Movantik or placebo once daily for 12 weeks. The trials were designed to measure the change in the number of bowel movements per week from the start of the study.

Results of the first trial showed that 44% of participants receiving 25 mg of Movantik and 41% of participants receiving 12.5 mg of Movantik experienced an increase in bowel movements per week, compared to only 29% of control patients. A second trial showed similar results.

Common side effects of Movantik include abdominal pain, diarrhea, headache and the experience of excessive gas in the stomach or intestinal area (flatulence).

If you have opioid-induced constipation you should speak with your physicians about treatment options, including diet, use of laxatives, exercise, and when appropriate, prescription medications.


Updated on: 05/18/15