Naldemedine Therapy May Reduce Symptoms of Opioid-Induced Constipation

A man experiencing stomach pain
Researchers conducted a double-blind study to assess the effect of naldemedine therapy vs placebo in reducing symptoms associated with opioid-induced constipation.

The following article is part of conference coverage from the 2019 American Association of Nurse Practitioners Annual Meeting (AANP 2019) in Indianapolis, Indiana. Clinical Advisor’s staff will be reporting breaking news associated with research conducted by leading nurse practitioners. Check back for the latest news from AANP 2019.


Naldemedine therapy for 12 weeks is associated with a reduced risk of opioid-induced constipation symptoms and should incorporated into care regimens by nurse practitioners, according to research presented at the 2019 American Association of Nurse Practitioners (AANP) Annual Meeting, held June 18 to 23 in Indianapolis, Indiana.

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Researchers conducted 2 randomized, double-blind studies in which patients received naldemedine 0.2 mg taken once per day vs placebo for 12 weeks. Adult subjects with chronic, non-cancer pain and opioid-induced constipation were to assess the frequency over time of spontaneous bowel movements, complete spontaneous bowel movements, spontaneous bowel movements without straining, and spontaneous bowel movements with a Bristol Stool Scale score of 3 or 4. Patients were not permitted to take laxatives throughout the duration of the study.

A total of 1095 subjects were randomized; 549 patients to naldemedine and 546 to placebo. The average number of spontaneous bowel movements per week at baseline was 1.3. For all measures, naldemedine was associated with a significantly greater improvement from baseline at each week relative to placebo; however, naldemedine was associated with a greater incidence of gastrointestinal adverse effects such as abdominal pain, nausea, and diarrhea compared with placebo.

“Treatment with naldemedine over 12 weeks compared with placebo improved the frequency of bowel movements and was generally well-tolerated,” the authors concluded.  

Disclosure: Study authors are or have been employees of Shionogi, Inc.

For more coverage of AANP 2019, click here.


Vallerand AH, Wild J, Yamada T, Ferreira JCA, Hale M. Naldemedine addresses key symptoms of opioid-induced constipation: exploratory analyses from two phase 3 randomized controlled studies. Presented at: the 2019 American Association of Nurse Practitioners (AANP) Annual Meeting; June 18-23, 2019; Indianapolis, IN. Poster 35.

This article originally appeared on Clinical Advisor