CHMP Recommends Approval of Opioid-Induced Constipation Drug

Megan Brooks

December 14, 2018

The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of naldemedine (Rizmoic, Shionogi BV) for treatment of opioid-induced constipation in adults who have previously been treated with a laxative.

Naldemedine is a peripherally acting mu-opioid receptor antagonist that acts in tissues such as the gastrointestinal tract, thereby decreasing the constipating effects of opioids without reversing the central nervous system–mediated opioid effects, the EMA explained in a news release.

Naldemedine has been shown to induce clinically relevant increases in the number of spontaneous bowel movements in patients suffering from opioid-induced constipation.

The long-term safety of naldemedine was evaluated in patients with opioid-induced constipation and chronic noncancer pain in a 52-week, randomized, double-blind, phase 3 study. Eligible adults who could be taking a routine laxative regimen were randomly assigned to receive either once-daily oral naldemedine 0.2 mg or placebo. There were 623 patients in each arm of the study.

Sustained significant improvements in bowel movement frequency and overall constipation-related symptoms and quality of life were observed with naldemedine (P ≤ .0001 vs placebo at all time points). The study was published in the journal Pain earlier this year.

The most common side effects are abdominal pain (7.8%), diarrhea (5.9%), nausea (3.6%), and vomiting (1.1%).

The summary of product characteristics will include detailed recommendations for use of naldemedine and will be published in the European public assessment report, which will be made available in all official European Union languages after the European Commission grants marketing authorization.

Upon approval, naldemedine will be available as 200-microgram film-coated tablets.

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