Naldemedine shows promise in treating OIC in patients with chronic non-cancer pain.

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."


Shionogi Inc.


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