Naloxegol for Opioid-Induced Constipation in Patients with Noncancer Pain

2 RCTs (n= 652; n=700) found treatment with naloxegol vs. placebo resulted in significantly higher rate of treatment response at wk 12, without reducing opioid-mediated analgesia (25 mg group, response = 44.4% vs. 29.4%, p=0.001 in 1 study and 39.7% vs. 29.3%, p= 0.02 in other).

Response was defined as ≥3 spontaneous bowel movements per week and an increase from baseline of ≥1 spontaneous bowel movements for ≥9 of 12 weeks and for ≥3 of the final 4 weeks.

 

In September 2013, the European Medicines Agency accepted the Marketing Authorisation Application for naloxegol, a peripherally-acting opioid antagonist, for the treatment of opioid-induced constipation in adults with chronic non-cancer pain.