Shionogi announced that oral naldemedine met its primary endpoints in a Phase 3 study (COMPOSE II) for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.

COMPOSE II is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of naldemedine therapy vs. placebo in 553 patients receiving chronic opioid therapy for at least three months, and who experience OIC accompanied by chronic non-cancer pain.

Study results showed that a 0.2mg tablet of naldemedine given once daily significantly improved the frequency of spontaneous bowel movement (SBM) compared with placebo over 12 weeks. This is the third Phase 3 trial in which naldemedine met its primary endpoints. Shionogi previously announced that COMPOSE I and COMPOSE IV met their endpoints.

Naldemedine is an investigational, oral, peripherally acting mu-opioid receptor antagonist (PAMORA).

Positive Results for Third Naldemedine Phase 3 Study in OIC

Want to read more?