Treatment with naldemedine improved opioid-induced consiptation in a timely manner and was well tolerated in patients with cancer, according to a study presented at the European Society for Medical Oncology (ESMO) 2016 Congress.1
Patients with cancer pain frequently receive opioids; however, many experience opioid-induced constipation as an adverse event of these analgesics. Therefore, researchers sought to evaluate the efficacy and safety of naldemedine, a peripherally acting opioid receptor antagonist, for the treatment of opioid-induced constipation.
For the double-blind, placebo-controlled, phase 3 trial, researchers in Japan enrolled 193 patients with cancer and opioid-induced constipation, defined as having 5 or fewer spontaneous bowel movements during a 2-week qualification period. Participants were randomly assigned to receive naldemedine orally or placebo.
Results showed that 71.1% of patients treated with placebo had 3 or more spontaneous bowel movements per week and an increase from baseline of 1 or more bowel movements per week during the 2-week treatment period compared with 34.4% of those who received naldemedine (P <.0001).
In addition, researchers found that naldemedine was associated with a shorter time to onset of action and a shorter median time to the first spontaneous bowel movement after initial dose compared with placebo.
The most common adverse event in the naldemedine group was diarrhea, with most cases reported as mild and all patients recovering.
1. Murata T, Katakami N, Harada T, et al. Treatment of opioid-induced constipation with naldemedine in patients with cancer: onset of action in a randomized phase 3 trial. Poster presented at: European Society for Medical Oncology (ESMO) 2016 Congress; October 7-11, 2016; Copenhagen, Denmark.