Naldemedine meets primary and secondary endpoints in phase III study for OIC treatment

Naldemedine, an investigational peripherally acting mu-opioid receptor antagonist (PAMORA) under development by Shionogi & Co., Ltd., met its primary and secondary endpoints in a phase III study (COMPOSE I) for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain receiving opioid therapy. Study results showed that naldemedine (0.2 mg tablet given once daily) statistically significantly improved the frequency of spontaneous bowel movement (SBM) compared with placebo over 12 weeks. Naldemedine was generally well-tolerated with the most commonly reported side effects being gastrointestinal disorders. This is the first phase III data generated from the COMPOSE program.

"OIC 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 Clinical Development. "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."

SOURCE Shionogi & Co., Ltd.