Shionogi today announced that once-daily naldemedine met its primary and secondary endpoints in a phase III study (COMPOSE II) for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain. Naldemedine is an investigational, oral, peripherally acting mu-opioid receptor antagonist (PAMORA). This is the third Phase III trial in which naldemedine met its primary and key secondary endpoints.
Study results showed that a 0.2 mg tablet of naldemedine given once daily 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.
"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 OIC," said Juan Camilo Arjona Ferreira, MD, Senior Vice President Clinical Development. "OIC is different from other forms of constipation as it is the most common side effect of chronic opioid therapy. OIC can hamper everyday activities, reduce work productivity and negatively affect a person's well-being."
The COMPOSE program is a global comprehensive development program comprised of seven clinical studies being conducted in patients with OIC with cancer or chronic non-cancer pain.
COMPOSE II is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. The study was designed to evaluate the efficacy and safety of naldemedine therapy, versus placebo, in 553 patients receiving chronic opioid therapy for at least three months, and who experience OIC accompanied by chronic non-cancer pain.
Shionogi previously announced that naldemedine met its primary and key secondary endpoints in COMPOSE I and COMPOSE IV. COMPOSE I evaluated the efficacy and safety of naldemedine therapy, versus placebo, in patients receiving chronic opioid therapy, who experience OIC accompanied by chronic non-cancer pain. COMPOSE IV was conducted in Japan and evaluated the efficacy and safety of naldemedine therapy, versus placebo, in patients receiving chronic opioid therapy for cancer pain and who experience OIC.