Shionogi Inc. today announced data from a Phase IIb study that showed 0.2 mg and 0.4 mg of naldemedine demonstrated statistically significant efficacy in treating opioid-induced constipation (OIC) in patients with chronic non-cancer pain. Naldemedine is an investigational, oral, peripherally acting mu-opioid receptor antagonist (PAMORA). The data, which are being presented today as a late-breaker (abstract #901e) at the Digestive Disease Week meeting in Washington, D.C., also showed that naldemedine was generally well-tolerated at both doses. Naldemedine is currently being evaluated in multiple Phase III studies.
"Opioid-induced constipation is the most commonly reported side effect of chronic opioid therapy, and can severely impact a patient's health and well-being," said Lynn Webster, MD, Vice President of Scientific Affairs, PRA Health Sciences and an investigator participating in the study. "The results of this study are encouraging for patients with OIC."