Year 2017 / Volume 109 / Number 11
Special Article
Eluxadoline in the treatment of diarrhea-predominant irritable bowel syndrome. The SEPD perspective

788-794

DOI: 10.17235/reed.2017.5078/2017

Isabel Vera, F. Javier Júdez,

Abstract
Functional gut disorders, including diarrhea-predominant irritable bowel syndrome, are highly prevalent conditions worldwide that significantly impact health economy and patient quality of life, yet lacking fully satisfactory therapeutic options. These circumstances fostered research on various molecules with more specific therapeutic targets, including opioid receptors. Eluxadoline (Allergan’s Vibercy® in the USA, Truberzi® in Europe) is a locally-acting mixed mu- and kappa-opioid receptor agonist, and delta-opioid receptor antagonist, that was licensed in 2015 by the Food and Drug Administration (FDA) and in 2016 by the European Medicines Agency (EMA) for use in diarrhea-predominant irritable bowel syndrome. Eluxadoline provides, with advantage over the current standard of care, control of both stool consistency and abdominal pain, good tolerability in most cases, and improved quality of life, hence it deserves consideration when approaching a patient with this disorder. As with any recently approved therapy, adequate pharmacovigilance is to be expected, as well as studies to inform on different scenarios such as on-demand therapy, loss of response assessment, use as rescue therapy for other molecules, and cost-effectiveness, to further characterize and more accurately position eluxadoline within the therapeutic spectrum.
Share Button
New comment
Comments
No comments for this article
References
1. Lowel RM, Ford AC. Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis. Clin Gastroenterol Hepatol 2012;10:712-721.
2. Scarpellini E, Laterza L, Ianiro G, et al. Eluxadoline for the treatment of diarrhoea-predominant irritable bowel syndrome. Expert Opin Pharmacother. 2016; 17(10): 1395-402.
3. Actavis. Actavis receives FDA approval for VIBERZI (eluxadoline) for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. 2015 May 27. http://www.actavis.com
4. U.S. Food and Drug Administration. FDA approves two therapies to treat IBS_D (2015 May 27) . https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm448328.htm
5. Truberzi. Initial Public Assessment Report. (EMA/549473/2016) 2016 Jul 21 http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/004098/WC500213370.pdf
6. Lembo AJ, Lacy BE, Zucherman MJ, et al. Eluxadoline for irritable bowel syndrome with diarrhea. N Engl J Med. 2016;374:242-253.
7. Mearín F, Badia X, Balboa A, et al. Irritable bowel syndrome prevalence varies enormously depending on the employed diagnostic criteria: comparison of Rome II versus previous criteria in a general population. Scand J Gastroenterol 2001;36:1155-1161.
8. Almansa C, Díaz-Rubio M, Rey E. The burden and management of patients with IBS: Results from a survey in Spanish gastroenterologists. Rev Esp Enferm Dig 2011,103:570-575.
9. Mearin F. Irritable bowel syndrome (IBS) subtypes: nothing resembles less an IBS than another IBS. Rev Esp Enferm Dig. 2016;108(2):57-8.
10. Mira JJ, Guilabert M, Sempere L, et al. The irritable bowel syndrome care process form the patients and professionals views. Rev Esp Enferm Dig 2015;107:202-210.
11. Drossman DA, Corazziari E, Delvaux M, et al. Rome III. The Functional Gastrointestinal disorders. 2006: 130 ed; 1377–1556.
12. Lacy BE, Mearin F, Chang L, et al. Bowel Disorders. Gastroenterology 2016;150:1393-1407.
13. Blake MR, Raker JM, Whelan K. Validity and reliability of the Bristol Stool Form Scale in healthy adults and patients with diarrhoea-predominant irritable bowel syndrome. Aliment Pharmacol Ther. 2016 Oct;44(7):693-703.
14. Ballou S, Bedell A, Keefer L. Psychosocial impact of irritable bowel syndrome: A brief review. World J Gastrointest Pathophysiol. 2015 Nov 15;6(4):120-3.
15. Martínez C, Lobo B, Pigrau M, et al. Diarrhoea-predominant irritable bowel syndrome: an organic disorder with sctructural abnormalities in the jejunal epitelial barrier. Gut 2013;62(8):1160-8.
16. Lembo A, Pimentel M, Raso SS, et al. Efficacy and safety of repeat treatment with rifaximin for diarrhea-predominant irritable bowel syndrome (IBS-D): results of the TARGET 3 study. Paper presented at the 2014 Annual Scientific Meeting of the American College of Gastroenterology; 2014 Oct 17-22; Philadelphia PA
17. Kane JS. Ford AC. Rifaximin for the treatment of diarrhea-predominant irritable bowel syndrome. Expert Rev Gastroenterol Hepatol. 2016;10(4):431-42.
18. Tiequn B, Guanqun C, Shuo Z. Therapeutic effects of Lactobacillus in treating irritable bowel syndrome: a meta-analysis. Intern Med. 2015;54:243-9.
19. Hanauer SB. The role of loperamide in gastrointestinal disorders. Rev Gastroenterol Disord. 2008;8:15-20.
20. Efskind PS, Bernklev T, Vatn MH. A double-blind placebo-controlled trial with loperamide in irritable bowel syndrome. Scand J Gastroenterol 1996;31:463-8.
21. Brandt LJ, Chey WD, Foxx-Orenstein AE, et al. An evidence-based position statement on the management of irritable bowel syndrome. Am J Gastroenterol 2008;104:S1-S35
22. Ford AC, Brandt LJ, Young C, et al. Efficacy of 5-HT3 antagonist and 5-HT4 agonist in irritable bowel syndrome: systematic review and meta-analysis. Am J Gastroenterol 2009;104:1831-43.
23. Chiba T, Yamamoto K, Sato S, et al. Long-term efficacy and safety of ramosetron in the treatment of diarrhea-predominant irritable bowel syndrome. Clin Exp Gastroenterol. 2013;6:123-8.
24. Brown PM, Drossman DA, Wood AJ, et al. The tryptophan hydrolase inhibitor LX1031 shows clinical benefit in patients with nonconstipating irritable bowel syndrome. Gastroenterology 2011;141:507-16.
25. Wood JD, Galligan JJ. Function of opioids in the enteric nervous system. Neurogastroenterol Motil. 2004;16 Suppl 2:17-28.
26. Wade PR, Palmer JM, McKenney S, et al. Modulation of gastrointestinal function by MuDelta a mixed mu opioid receptor agonist/delta opioid receptor antagonist. Br J Pharmacol 2012;167;1111-25.
27. Fujita W, Gomes I, Dove LS, et al. Molecular characterization of eluxadoline as a potential ligand targeting mu-delta opioid receptor heteromers. Biochem Pharm 2014;92:448-56.
28. Dove LS, Lembo A, Randall CW, et al. Eluxadoline benefits patients with irritable bowel with diarrhea in a Phase 2 study. Gastroenterology 2013;145:329-38.
29. Lacy BE, Emerging treatment in neurogastroenterology: eluxadoline- a new therapeutic option for diarrhea predominant IBS. Neurogastroenterol Motil 2016;28:26-35.
30. Fant RV, Henningfield JE, Cash BD, Dove LS, Covington PS. Eluxadoline Demonstrates a Lack of Abuse Potential in Phase 2 and 3 Studies of Patients With Irritable Bowel Syndrome With Diarrhea. Clin Gastroenterol Hepatol. 2017 Feb 3. pii: S1542-3565(17)30134-9. doi: 10.1016/j.cgh.2017.01.026. [Epub ahead of print]
31. Truberzi. Eluxadoline. EPAR Summary for the public. EMA/CHMP/517539/2016 (EMEA/H/C/004098). Sep. 2016. http://www.ema.europa.eu/ema/index.jsp?curl=/pages/medicines/human/medicines/004098/human_med_002025.jsp&mid=WC0b01ac058001d124
32. Product information: Truberzi. EMEA/H/C/004098 -IB/0002/G (First published: 29 sep 2016; Last updated: 15 mar 2017). http://www.ema.europa.eu/ema/index.jsp?curl=/pages/medicines/human/medicines/004098/human_med_002025.jsp&mid=WC0b01ac058001d124
33. Viberzi (eluxadoline): Drug Safety Communication - Increased Risk of Serious Pancreatitis In Patients Without A Gallbladder. FDA. 2017 Mar 15. https://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm546771.htm
Related articles

Letter

Lymphocytic colitis with macroscopic findings

DOI: 10.17235/reed.2023.9497/2023

Digestive Diseases Image

Whipple’s disease – A typical endoscopic finding of a rare disease

DOI: 10.17235/reed.2022.9338/2022

Letter

Diarrhea and monkeypox: a consideration

DOI: 10.17235/reed.2022.8957/2022

Digestive Diseases Image

Villous atrophy, an endoscopic and diagnostic challenge

DOI: 10.17235/reed.2021.8169/2021

Digestive Diseases Image

Gastroduodenal Burkitt’s lymphoma: a rare cause of epigastric pain and diarrhea

DOI: 10.17235/reed.2021.8150/2021

Original

Chronic diarrhea due to autoimmune enteropathy

DOI: 10.17235/reed.2020.7218/2020

Letter

An uncommon cause of chronic abdominal pain and diarrhea

DOI: 10.17235/reed.2020.6657/2019

Special Article

Consensus document on exclusion diets in irritable bowel syndrome (IBS)

DOI: 10.17235/reed.2018.5941/2018

Letter

Keriorrhea (waxy diarrhea), a new sign to bear in mind

DOI: 10.17235/reed.2018.5614/2018

Letter to the Editor

Diarrhea caused by multiparasitic infection

DOI: 10.17235/reed.2016.4100/2015

Citation tools
Vera I, Júdez F. Eluxadoline in the treatment of diarrhea-predominant irritable bowel syndrome. The SEPD perspective. 5078/2017


Download to a citation manager

Download the citation for this article by clicking on one of the following citation managers:

Metrics
This article has received 1027 visits.
This article has been downloaded 293 times.

Statistics from Dimensions


Statistics from Plum Analytics

Publication history

Received: 23/05/2017

Accepted: 14/07/2017

Online First: 27/07/2017

Published: 02/11/2017

Article revision time: 48 days

Article Online First time: 65 days

Article editing time: 163 days


Share
This article has been rated by 1 readers.
Reader rating:
Valora este artículo:




Asociación Española de Ecografía Digestiva Sociedad Española de Endoscopia Digestiva Sociedad Española de Patología Digestiva
The Spanish Journal of Gastroenterology is the official organ of the Sociedad Española de Patología Digestiva, the Sociedad Española de Endoscopia Digestiva and the Asociación Española de Ecografía Digestiva
Cookie policy Privacy Policy Legal Notice © Copyright 2023 y Creative Commons. The Spanish Journal of Gastroenterology