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Naldemedine Shows Promise in Treatment of Opioid-Induced Constipation

Drug meets primary and secondary endpoints in phase III study

A phase III trial of once-daily naldemedine (Shionogi Inc.), an investigational peripherally acting mu opioid receptor antagonist (PAMORA), has met its primary and secondary endpoints in adult patients with chronic noncancer pain and opioid-induced constipation (OIC). This is the third phase III study in which naldemedine reached its primary and key secondary goals.

The COMPOSE II trial was a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. It was designed to evaluate the efficacy and safety of naldemedine compared with placebo in 553 patients who had experienced chronic noncancer pain accompanied by OIC during at least 12 weeks of opioid therapy.

The study results showed that a 0.2-mg tablet of naldemedine administered once daily significantly improved the frequency of spontaneous bowel movements (SBMs) compared with placebo during 12 weeks of treatment. The most common adverse events associated with naldemedine were gastrointestinal disorders.

OIC is characterized by any of the following symptoms: reduced bowel movement frequency; the development or worsening of straining to pass bowel movements; a sense of incomplete rectal evacuation; or harder stool consistency. It has been estimated that 40% to 50% of patients receiving chronic opioid therapy –– approximately 11 million Americans –– experience OIC, with fewer than half reporting satisfactory results with laxatives.

Source: Shionogi Inc.; August 3, 2015.


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