An investigational drug reduces constipation among patients taking opioids for noncancer pain, according to two phase-III, industry-funded studies reported in the New England Journal of Medicine.
The trials, conducted in the U.S. and Europe, together enrolled nearly 1400 adults who had been taking an oral opioid for noncancer pain for at least 4 weeks and had confirmed opioid-induced constipation. Patients were randomized to 12.5 or 25 mg/day of naloxegol, a peripheral μ-opioid receptor antagonist, or placebo for 12 weeks. Response was defined as three or more spontaneous bowel movements per week and an increase in bowel movements over baseline.
In both studies, patients taking 25 mg of naloxegol had a significantly higher response rate than those taking placebo (roughly 40% vs. 30%). The 12.5-mg dose was significantly better than placebo in only one of the studies.
Adverse events were highest in the 25-mg group and were most often gastrointestinal.