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COMPOSE III: Naldemedine safe for long-term treatment of OIC

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Naldemedine was safe and well tolerated through 52 weeks for treating opioid-induced constipation in patients with chronic noncancer pain, according to research presented at PAINWeek 2016.

Naldemedine (Shionogi) is a peripherally-acting mu-opioid receptor antagonist previously shown to improve opioid-induced constipation (OIC) in patients with chronic noncancer pain in the COMPOSE I, II and IV studies. The global COMPOSE development program includes seven total trials in patients with OIC and cancer or chronic noncancer pain.

“We’ve seen these good results in earlier 3-month studies of naldemedine, but now we have evidence of similar positive outcomes in patients on the treatment for 1 year,” Juan Camilo Arjona Ferreira, MD, senior vice president of clinical development at Shionogi, said in a press release. “This is encouraging news for chronic non-cancer pain patients with OIC, who suffer with this condition and are seeking safe and effective treatment options.”

In COMPOSE III, a multicenter, randomized, double blind, placebo-controlled, parallel-group trial, about 620 adults with OIC and chronic noncancer pain who were either on or off laxatives received once daily naldemedine for 52 weeks, and about the same number received placebo. The treatment group showed significant improvements in weekly bowel movement frequency compared with placebo at all time points measured (P ≤ .0001) and no significant opioid withdrawal signs or symptoms.

Treatment-emergent adverse events were similar (68.4% vs. 72.1%), and GI side effects reported in more than 5% of the treatment group and more frequently than in the placebo group included abdominal pain (8.2% vs. 3.1%), diarrhea (11% vs. 5.3%) and vomiting (6% vs. 3.1%).

Shionogi previously submitted New Drug Applications for naldemedine in the U.S. (for OIC in adults with chronic noncancer pain) and Japan (for OIC in adults). The FDA has accepted the NDA for review, and the target action date under the Prescription Drug User Fee Act is March 23, 2017, according to the press release.

Disclosures: Ferreira is employed by Shionogi.