Shionogi’s Phase III trial of constipation drug naldemedine meets primary endpoint

Japanese pharmaceutical firm Shionogi has reported positive results from its Phase III trial (COMPOSE I) of naldemedine, an investigational peripherally acting mu-opioid receptor antagonist (PAMORA), to treat opioid-induced constipation (OIC).

The Phase III trial, which was designed to evaluate the efficacy and safety of naldemedine therapy, versus placebo, showed that naldemedine met its primary and secondary endpoints in the treatment of OIC in adult patients with chronic non-cancer pain receiving opioid therapy.

Results showed that naldemedine 0.2mg tablet given once daily statistically significantly improved the frequency of spontaneous bowel movement (SBM) compared with placebo over 12 weeks.

In the trial, naldemedine was generally well-tolerated with the most commonly reported side effects being gastrointestinal disorders.

The company said that this is the first Phase III data generated from the COMPOSE programme, which comprised of seven clinical trials being conducted in patients with OIC with cancer or chronic non-cancer pain.

Shionogi Clinical Development senior vice-president Dr Juan Camilo Arjona Ferreira said: "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.

"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."

A total of 547 patients receiving chronic opioid therapy, who experience OIC accompanied by chronic non-cancer pain, were included in the multicentre, randomised, double-blind, placebo-controlled, parallel-group COMPOSE I trial.