Eluxadoline (Truberzi®) is an orally administered, minimally absorbed agent that acts locally in the gastrointestinal tract as a mixed µ-opioid receptor agonist and δ-opioid receptor antagonist. The randomized, double-blind, placebo-controlled, multinational, phase 3 IBS-3001 and IBS-3002 trials examined the efficacy of eluxadoline in patients with diarrhoea-predominant irritable bowel syndrome (IBS-D). The composite response rate (i.e. the proportion of patients with improvement in both worst abdominal pain and stool consistency on ≥50% of days; primary endpoint), was significantly higher in patients receiving eluxadoline 100 mg twice daily than in those receiving placebo after 12 and 26 weeks’ therapy. Other abdominal and bowel symptoms (e.g. bloating, urgency, frequency of bowel movement) and health-related quality of life scores were also improved with eluxadoline. Eluxadoline was generally well tolerated in patients with IBS-D. Constipation was the most commonly occurring adverse event, although no serious constipation events were reported. Pancreatitis and adverse events consistent with sphincter of Oddi spasm were uncommon. In conclusion, eluxadoline is a new option to consider in the treatment of adult patients with IBS-D.
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During the peer review process, the manufacturer of eluxadoline was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.
The preparation of this review was not supported by any external funding.
Conflicts of interest
Gillian Keating is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.
The manuscript was reviewed by: B.D. Cash, University of Southern Alabama, Gastroenterology Division, Mobile, AL, USA; F. Mearin, Centro Médico Teknon, Institute of Functional and Motor Digestive Disorders, Barcelona, Spain; E. Rey, Hospital Clínico San Carlos, Division of Digestive Diseases, Universidad Complutense, Madrid, Spain; L.R. Schiller, Baylor University Medical Center, Division of Gastroenterology, Dallas, TX, USA.
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Keating, G.M. Eluxadoline: A Review in Diarrhoea-Predominant Irritable Bowel Syndrome. Drugs 77, 1009–1016 (2017). https://doi.org/10.1007/s40265-017-0756-7