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Phase III Study: Naloxegol Improves Opioid-Induced Constipation

Drug compared with placebo in 3-month trial (Nov. 12)

Positive top-line results have been reported from two phase III trials and one safety extension trial in patients with non–cancer-related pain and opioid-induced constipation (OIC). These studies evaluated the safety and efficacy of naloxegol (AstraZeneca) –– an oral, peripherally acting mu-opioid receptor antagonist for the treatment of OIC, a common side effect of prescription opioids.

KODIAC-04 and KODIAC-05 are multicenter, randomized, double-blind, placebo-controlled pivotal trials of 12 weeks duration evaluating naloxegol 12.5 mg and 25 mg administered once daily. The primary endpoint in both trials was the percentage of OIC responders versus placebo over 12 weeks of treatment. A responder was defined as having at least three spontaneous bowel movements (SBMs) per week, with an increase of at least one SBM per week over baseline, for at least 9 out of 12 weeks, and at least 3 out of the last 4 weeks.

In the KODIAC-04 trial, both naloxegol doses (12.5 mg and 25 mg) demonstrated statistically significant results for the primary endpoint. The P values were 0.015 and 0.001, respectively.