Shionogi's naldemedine meets primary endpoint in Phase III study for opioid-induced constipation

Japanese pharma company Shionogi (TYO: 4507) says that its investigational peripherally-acting mu-opioid receptor antagonist naldemedine has met its primary and secondary endpoints at Phase III in opioid-induced constipation.

The trial looked at adult patients with chronic non-cancer pain receiving opioid therapy. Results showed that naldemedine 0.2mg once daily statistically significantly improved the frequency of spontaneous bowel movement compared with placebo over 12 weeks. The drug was generally well-tolerated, and the most commonly-reported side effects were gastrointestinal disorders.

Juan Camilo Arjona Ferreira, senior vice president of clinical development, 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 Save this debilitating condition."