Data from three randomized trials show no signs of abuse potential for 75, 100 mg eluxadoline
MONDAY, July 10, 2017 (HealthDay News) — For patients with irritable bowel syndrome with diarrhea (IBS-D), there are no signs of abuse potential for eluxadoline, according to a study published in the July issue of Clinical Gastroenterology and Hepatology.
Reginald V. Fant, Ph.D., from Pinney Associates in Bethesda, Md., and colleagues examined the abuse potential of eluxadoline in one phase 2 and two phase 3 randomized controlled trials. Enrolled patients met the Rome III criteria for IBS-D and received twice-daily treatment with eluxadoline or placebo for 12, 26, or 52 weeks; with 807 and 1,032 patients receiving one or more doses of 75 or 100 mg eluxadoline, respectively, and 975 receiving placebo.
The researchers found that there was no significant difference between the groups in terms of adverse events potentially related to abuse (2.8, 2.7, and 4.3 percent, respectively, for those given placebo, eluxadoline 75 mg, or eluxadoline 100 mg). Anxiety and somnolence were the most common adverse events potentially related to abuse, and they occurred in fewer than 2 percent of patients in each group. There was no significant difference between the groups in terms of the median overall Subjective Opiate Withdrawal Scale scores (3, 2, and 3, respectively, for those given placebo, eluxadoline 75 mg, and eluxadoline 100 mg).
“In an analysis of data from Phase 2 and Phase 3 trials of eluxadoline (75 or 100 mg) for patients with IBS-D, data revealed no signs of abuse potential for eluxadoline,” the authors write.
The study was funded by Furiex Pharmaceuticals, a subsidiary of Allergan, which manufactures eluxadoline.
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