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Naldemedine safely improved opioid-induced constipation in patients with chronic noncancer pain
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WASHINGTON — Patients with opioid-induced constipation and chronic noncancer pain achieved symptom improvement with naldemedine, according to data from a late-breaker abstract presented at Digestive Disease Week.
“Laxatives have traditionally been the first-line treatment for opioid-induced constipation but there is really very little clinical evidence for their efficacy and many patients cannot achieve satisfactory laxation with the use of laxatives,” Lynn R. Webster, MD, from PRA Health Sciences, Salt Lake City, Utah, said in his presentation. “Naldemedine is a new, novel peripherally acting mu-opioid receptor antagonist that falls into the category that we call PAMORA being developed for the treatment of opioid-induced constipation.”
Webster and colleagues performed a phase 2b study of oral naldemedine (Shionogi) in 244 patients with chronic noncancer pain and opioid-induced constipation for at least 3 months and fewer than three spontaneous bowel movements per week during the screening period. Patients were randomly assigned to receive placebo or 0.1 mg, 0.2 mg or 0.4 mg naldemedine once daily for 4 weeks, and the primary endpoint was increase in spontaneous bowel movement in the last 2 weeks of the study period compared with placebo.
The primary endpoint was achieved with significance in the 0.2 mg (P = .0014) and 0.4 mg (P = 0.0003) groups. Compared with placebo the proportion of responders was 71.2% (P = 0.0005) for the 0.2 mg group and 66.7% (P = 0.003) for the 0.4 mg group. The most common treatment-emergent adverse events were abdominal pain, diarrhea, flatulence and nausea, and most were mild to moderate in severity. No significant changes in Clinical Opiate Withdrawal Scale questionnaire and 11-point Numerical Rating Scale pain questionnaire scores were observed in the treatment groups.
Naldemedine “significantly increased the number of spontaneous bowel movements per week in patients with chronic noncancer pain and [opioid-induced constipation] compared to placebo,” Lynn concluded. “Naldemedine was generally well tolerated. The most frequent treatment effects were GI which is consistent with naldemedine’s mechanism of action … and 0.2 mg once a day was selected for phase 3 development, which is ongoing at this time.” – by Adam Leitenberger
For more information:
Webster LR, et al. Abstract 901e. Presented at: Digestive Disease Week, May 16-19, 2015; Washington, D.C.
Disclosure: Webster’s relevant financial disclosures were not available in the DDW faculty index. Please see the DDW faculty disclosure index for all other researchers’ relevant financial disclosures.