Oral naldemedine 0.2 mg once daily is a safe and effective treatment option for opioid-induced constipation (OIC) in patients with cancer pain, according to a study published in the Journal of Clinical Oncology.

Opioid administration is a commonly utilized treatment in the management of moderate to severe cancer pain but is frequently associated with OIC, an adverse event (AE) that affects up 60% to 90% of patients. OIC has a negative impact on patients’ quality of life and may disrupt patient adherence to opioid regimens, reducing the effectiveness of treatment.

This phase 3 study was comprised of 2 parts: the 2-week COMPOSE-4 study for which investigators assigned 193 patients to receive naldemedine 0.2 mg or placebo, and the 12-week extension study COMPOSE-5.

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The primary outcome measure for COMPOSE-4 was the proportion of spontaneous bowel movement (SBM) responders, defined as 3 or more SBMs per week and an increase of 1 or more SBMs from baseline, and COMPOSE-5 assessed safety outcomes.

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Results of the COMPOSE-4 study demonstrated that the naldemedine arm had a greater proportion of SBM responders with 71.1% compared with just 34.4% in the placebo arm (P <.0001).

Patients in the naldemedine arm also achieved a greater improvement from baseline compared with the placebo arm, with more SBMs per week (5.16 vs 1.54; P <.0001), SBMs with complete bowel evacuations per week (2.76 vs 0.71; P <.0001), and SBMs without straining per week (3.85 vs 1.17; P =.0005).

The reported rate of treatment-emergent AEs (TEAE) in COMPOSE-4 was 44.3% and 26.0% in the naldemedine arm and placebo arm, respectively, and in COMPOSE-5, 80.2% of patients in the naldemedine arm reported TEAEs. The most frequently reported AE in both studies was diarrhea.

Patients treated with naldemedine did not present with signs or symptoms of opioid withdrawal and did not report any decrease in opioid effectiveness.

The authors of the study concluded that the “results highlight the utility of once-daily oral naldemedine 0.2 mg taken with or without food as an effective treatment option for patients with OIC and cancer.”


1. Katakami N, Harada T, Murata T, et al. Randomized phase III and extension studies of naldemedine in patients with opioid-induced constipation and cancer [published online October 2, 2017]. J Clin Oncol. doi: 10.1200/JCO.2017.73.0853