# PubMed- Eluxadoline Benefits Patients with Irritable Bowel Syndrome with Diarrhea in a Phase 2 Study.



## VSsupport (Feb 12, 2008)

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*Eluxadoline Benefits Patients with Irritable Bowel Syndrome with Diarrhea in a Phase 2 Study.*

Gastroenterology. 2013 Apr 9;

Authors: Dove LS, Lembo A, Randall CW, Fogel R, Andrae D, Davenport JM, McIntyre G, Almenoff JS, Covington PS

Abstract
BACKGROUND & AIMS: Simultaneous agonism of the µopioid receptor (MOR) and antagonism of the Î´opioid receptor (DOR) can reduce abdominal pain and diarrhea in patients with irritable bowel syndrome with diarrhea (IBS-D) without constipating side effects. We evaluated the efficacy and safety of a minimally absorbed, MOR agonist and DOR antagonist (eluxadoline) in a Phase 2 study in patients with IBS-D. METHODS: We randomly assigned 807 patients to groups that received oral placebo twice daily or 5, 25, 100, or 200 mg oral eluxadoline for 12 weeks. The primary endpoint was clinical response at week 4, defined by an average reduction in daily pain score from baseline of 30% or more, and of at least 2 points on 0-10 scale, as well as a stool consistency score of 3 or 4 for at least 66% of daily diary entries during that week. RESULTS: Significantly more patients receiving 25 mg (12.0%) or 200 mg (13.8%) eluxadoline met the primary endpoint of clinical response than patients given placebo (5.7%; P <.05). Patients receiving eluxadoline at 100 mg and 200 mg also had greater improvements in bowel movement frequency and urgency, global symptoms, quality of life, and adequate relief assessments (P <.05). Additionally, patients receiving 100 mg (28.0%) or 200 mg (28.5%) eluxadoline were significantly more likely than those receiving placebo (13.8%; P <.005) to meet the FDA response endpoint over the full 12 weeks of the study. Eluxadoline was well tolerated with a low incidence of constipation. CONCLUSIONS: In a Phase 2 study of the mixed MOR agonist/DOR antagonist eluxadoline vs placebo in patients with IBS-D, patients given eluxadoline were significantly more likely to be clinical responders, based on a composite of improvement in abdominal pain and stool consistency. Further study of eluxadoline is warranted to assess its potential as a treatment for IBS-D. ClinicalTrials.gov number, NCT01130272.

PMID: 23583433 [PubMed - as supplied by publisher]

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