Safety of Eluxadoline in Patients with Irritable Bowel Syndrome with Diarrhea.

ABSTRACT:

Objectives

Eluxadoline is a mixed μ-opioid receptor (OR) and κ-OR agonist and δ-OR antagonist, approved for the treatment of irritable bowel syndrome with diarrhea (IBS-D). This analysis evaluated the safety and tolerability of eluxadoline 75 and 100 mg twice daily (BID) in one Phase 2 (IBS-2001) and two Phase 3 (IBS-3001 and IBS-3002) studies.

Methods

Adults with IBS-D (Rome III criteria) were randomized to placebo or eluxadoline (75 or 100 mg) BID for 12 (IBS-2001), 26 (IBS-3002), or 52 (IBS-3001) weeks. Safety data were pooled. Adverse events (AEs) were assessed, with special focus on opioid-related AEs, including suspected sphincter of Oddi spasm (SOS) events.

Results

2,776 patients were included in the enrolled set; the safety set comprised 2,814 patients, based

SUBMITTER: Cash BD 

PROVIDER: S-EPMC5318664 | biostudies-literature | 2017 Feb

REPOSITORIES: biostudies-literature