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Naldemedine improves opioid-induced constipation in third phase 3 trial
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Naldemedine, an investigational orally administered, peripherally acting mu-opioid receptor antagonist for the treatment of opioid-induced constipation in adults with chronic noncancer pain, met its primary and secondary endpoints in a third phase 3 trial, the manufacturer announced.
“We are very encouraged by the results of this study, as it brings us another step closer to our goal of delivering a new therapeutic solution to the millions of patients whose daily lives can be severely impacted by [opioid-induced constipation],” Juan Camilo Arjona Ferreira, MD, senior vice president of clinical development for Shionogi, said in a press release. “[Opioid-induced constipation] is different from other forms of constipation as it is the most common side effect of chronic opioid therapy. [It] can hamper everyday activities, reduce work productivity and negatively affect a person's well-being.”
Safety and efficacy of naldemedine (Shionogi) were previously demonstrated in COMPOSE I and COMPOSE IV.
COMPOSE II was a 12-week, double-blind, parallel-group, randomized controlled trial investigating safety and efficacy of naldemedine compared with placebo in 553 patients with opioid-induced constipation with chronic noncancer pain at multiple centers, according to the release. The results showed once-daily 0.2 mg naldemedine tablets increased spontaneous bowel movement frequency over the study period, and was generally well-tolerated. GI disorders were the most commonly reported side effects.
Seven clinical studies in total will be performed as part of the global COMPOSE development program, the release said.
Disclosure: Ferreira is an employee of Shionogi.