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Naldemedine improved opioid-induced constipation
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Naldemedine, an investigational peripherally acting mu-opioid receptor antagonist, safely and effectively treated opioid-induced constipation in a recent phase 3 study, the manufacturer announced.
According to data from the COMPOSE I trial, a multicenter, randomized, placebo-controlled trial, and the first of seven clinical studies in the global COMPOSE program, 0.2 mg naldemedine (Shionogi & Co.) once daily over 12 weeks significantly improved spontaneous bowel movement frequency compared with placebo in 547 adult patients with opioid-induced constipation related to chronic opioid therapy for non-cancer pain. The agent was also generally well-tolerated with gastrointestinal disorders being the most commonly reported side effect, according to the release.
Opioid-induced constipation “is one of the most common side effects of chronic opioid therapy, and can negatively impact a person’s quality of life, including limitations in daily activities, impairments in psychological well-being, and decreases in work productivity,” Juan Camilo Arjona Ferreira, MD, senior vice president of clinical development for Shionogi & Co., said in the release. “We are encouraged by the results of this study, and hope to deliver a new therapeutic solution to the millions of patients suffering from this debilitating condition.”