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Eluxadoline for Irritable Bowel Syndrome with Diarrhea
Open accessAbstract
Background Effective and safe treatments are needed for patients who have irritable bowel syndrome (IBS) with diarrhea. We conducted two phase 3 trials to assess the efficacy and safety of eluxadoline, a new oral agent with mixed opioid effects (μ- and κ-opioid receptor agonist and δ-opioid receptor antagonist), in patients with IBS with diarrhea. Methods We randomly assigned 2427 adults who had IBS with diarrhea to eluxadoline (at a dose of 75 mg or 100 mg) or placebo twice daily for 26 weeks (IBS-3002 trial) or 52 weeks (IBS-3001 trial). The primary end point was the proportion of patients who had a composite response of decrease in abdominal pain and improvement in stool consistency on the same day for at least 50% of the days from weeks 1 through 12 and from weeks 1 through 26. Results For weeks 1 through 12, more patients in the eluxadoline groups (75 mg and 100 mg) than in the placebo group reached the primary end point (IBS-3001 trial, 23.9% with the 75-mg dose and 25.1% with the 100-mg dose vs. 17.1% with placebo; P=0.01 and P=0.004, respectively; IBS-3002 trial, 28.9% and 29.6%, respectively, vs. 16.2%; P<0.001 for both comparisons). For weeks 1 through 26, the corresponding rates in IBS-3001 were 23.4% and 29.3% versus 19.0% (P=0.11 and P<0.001, respectively), and the corresponding rates in IBS-3002 were 30.4% and 32.7% versus 20.2% (P=0.001 and P<0.001, respectively). The most common adverse events associated with 75 mg of eluxadoline and 100 mg of eluxadoline, as compared with placebo, were nausea (8.1% and 7.5% vs. 5.1%), constipation (7.4% and 8.6% vs. 2.5%), and abdominal pain (5.8% and 7.2% vs. 4.1%). Pancreatitis developed in 5 (2 in the 75-mg group and 3 in the 100-mg group) of the 1666 patients in the safety population (0.3%). Conclusions Eluxadoline is a new therapeutic agent that reduced symptoms of IBS with diarrhea in men and women, with sustained efficacy over 6 months in patients who received the 100-mg dose twice daily. (Funded by Furiex Pharmaceuticals, an affiliate of Allergan; IBS-3001 and IBS-3002 ClinicalTrials.gov numbers, NCT01553591 and NCT01553747 , respectively.).
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“In the two phase 3 studies (IBS-3001 [52-week treatment] and IBS-3002 [26-week treatment]) evaluating the safety and efficacy of eluxadoline, the primary composite endpoint was defined as a concurrent $30% improvement in daily abdominal pain score compared with baseline and a BSS score ,5 on at least 50% of days withi…”
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“Three large clinical trials, involving a total of over 3000 patients randomized to eluxadoline or placebo, have demonstrated efficacy of eluxadoline in the relief of diarrhea or the composite endpoint of diarrhea and pain over 12 weeks of treatment [48,49].”
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“While a low incidence of pancreatitis with mild symptoms was also recognized (Dove et al., 2013; Lembo et al., 2016), post-marketing surveillance identi fi ed additional cases.”
BackgroundPlasse, T. F., Barton, G., Davidson, E., Abramson, D., Kalfus, I., Fathi, R., Raday, G., & Harris, M. S. (2020) · American Journal of Gastroenterology · doi:10.14309/ajg.0000000000000727 · Cited by 40
“The magnitude of effects was comparable with thosewith other approved products for IBS-D, alosetron (17,18), rifaximin (19), and eluxadoline (20) across all study end points.”
ResultDecraecker, L., Looze, D. D., Hirsch, D., Schepper, H. D. D., Arts, J., Caenepeel, P., Bredenoord, A., Kolkman, J., Bellens, K., Beek, K. V., et al. (2024) · Gut · doi:10.1136/gutjnl-2023-331634 · Cited by 39
Diabetes and the Small Intestine
Gotfried, J., Priest, S., & Schey, R. (2017) · Current Treatment Options in Gastroenterology · doi:10.1007/s11938-017-0155-x · Cited by 45
Self-citationNew advances in the treatment of paediatric functional abdominal pain disorders
Santucci, N. R., Saps, M., & van Tilburg, M. A. L. (2019) · The Lancet. Gastroenterology & hepatology · doi:10.1016/s2468-1253(19)30256-0 · Cited by 50
Diarrhea-predominant irritable bowel syndrome: Diagnosis, etiology, and new treatment considerations
Lacy, B. E., & Moreau, J. C. (2016) · Journal of the American Association of Nurse Practitioners · doi:10.1002/2327-6924.12387 · Cited by 40
“In clinical trials, this AE occurred during the first week of treatment and resolved with drug discontinuation (Lembo et al., 2016; VIBERZI (eluxadoline) tablets, for oral use, CIV, 2015).”
BackgroundInfluentialSelf-citationLacy, B. (2018) · Alimentary Pharmacology and Therapeutics · doi:10.1111/apt.14948 · Cited by 36
“has number needed to treat values of 10‐15, while eluxadoline 100 mg has number needed to treat values of 9‐13.(48) The most commonly reported AEs in the pooled eluxadoline population”
BackgroundMethodInfluentialSelf-citationExisting and Emerging Therapies for Managing Constipation and Diarrhea
Bharucha, A., Wouters, M., & Tack, J. (2017) · Current opinion in pharmacology (Print) · doi:10.1016/j.coph.2017.10.015 · Cited by 36
“Six weeks after the first retreatment, all patients were retreated again; again, the response to rifaximin was greater than placebo.[16] Adverse events, primarily headache, upper respiratory tract infection, and abdominal pain, were uncommon and similar between groups.”
BackgroundResultNeuroimmune factors in functional gastrointestinal disorders: A focus on irritable bowel syndrome
Boeckxstaens, G. E., & Wouters, M. M. (2016) · Neurogastroenterology & Motility · doi:10.1111/nmo.13007 · Cited by 37
Barberio, B., Savarino, E., Black, C., & Ford, A. (2021) · Clinical Gastroenterology and Hepatology · doi:10.1016/j.cgh.2021.08.025 · Cited by 35
G-protein–coupled receptors are dynamic regulators of digestion and targets for digestive diseases
Canals, M., Poole, D. P., Veldhuis, N. A., Schmidt, B. L., & Bunnett, N. W. (2019) · Gastroenterology · doi:10.1053/j.gastro.2019.01.266 · Cited by 35
Irritable Bowel Syndrome: Pathophysiology and Current Therapeutic Approaches.
Camilleri, M., & Ford, A. (2017) · Handbook of Experimental Pharmacology · doi:10.1007/164_2016_102 · Cited by 33
Gunn, D., Topan, R., Barnard, L., Fried, R., Holloway, I., Brindle, R., Corsetti, M., Scott, M., Farmer, A., Kapur, K., et al. (2023) · Alimentary Pharmacology and Therapeutics · doi:10.1111/apt.17426 · Cited by 32
Shah, E. D., Salwen‐Deremer, J. K., Gibson, P. R., Muir, J. G., Eswaran, S. L., & Chey, W. D. (2020) · Clinical Gastroenterology and Hepatology · doi:10.1016/j.cgh.2020.09.043 · Cited by 40
Sahu, A., Gaur, M., Mahanandia, N. C., Subudhi, E., Swain, R. P., & Subudhi, B. B. (2023) · Computers in Biology and Medicine · doi:10.1016/j.compbiomed.2023.106971 · Cited by 37
Acupuncture for Diarrhoea-Predominant Irritable Bowel Syndrome: A Network Meta-Analysis
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Sabaté, J., & Iglicki, F. (2022) · World Journal of Gastroenterology · doi:10.3748/wjg.v28.i7.732 · Cited by 32
DiCello, J. J., Carbone, S., Saito, A., Rajasekhar, P., Ceredig, R. A., Pham, V., Valant, C., Christopoulos, A., Veldhuis, N. A., Canals, M., et al. (2019) · Cellular and Molecular Gastroenterology and Hepatology · doi:10.1016/j.jcmgh.2019.11.006 · Cited by 34
Contribution of membrane receptor signalling to chronic visceral pain
Sadeghi, M., Erickson, A., Castro, J., Deiteren, A., Harrington, A. M., Grundy, L., Adams, D. J., & Brierley, S. M. (2018) · The International Journal of Biochemistry & Cell Biology · doi:10.1016/j.biocel.2018.02.017 · Cited by 40
Chey, W. D., Dove, L. S., Andrae, D. A., & Covington, P. S. (2017) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.14031 · Cited by 29
“3-month interval (weeks 1–12) and the 6-month interval (weeks 1–26).(14) Within the pooled ITT analysis set, 765 patients (31.”
BackgroundMethodResultInfluentialSelf-citationAbdominal Pain in Inflammatory Bowel Disease: An Evidence-Based, Multidisciplinary Review
Coates, M. D., Clarke, K., Williams, E. D., Jeganathan, N., Yadav, S., Giampetro, D., Gordin, V., Smith, S. E., Vrana, K. E., Bobb, A. D., et al. (2023) · Crohn's & Colitis 360 · doi:10.1093/crocol/otad055 · Cited by 28
“204 Serotonin receptor modulators—”
Holtmann, G., Schrenk, D., Madisch, A., Allescher, H. D., Ulrich-Merzenich, G. S., Mearin, F., Larrey, D. G., & Malfertheiner, P. (2019) · Digestive Diseases · doi:10.1159/000504570 · Cited by 29
An evidence-based update on the diagnosis and management of irritable bowel syndrome
Black, C. J., & Ford, A. C. (2025) · Expert Review of Gastroenterology & Hepatology · doi:10.1080/17474124.2025.2455586 · Cited by 27
“Eluxadoline has been evaluated in two placebo-controlled trials recruiting over 2400 patients [98].”
Li, X.-M., Yuan, Q., Huang, H., & Wang, L. (2025) · Frontiers in Immunology · doi:10.3389/fimmu.2025.1695321 · Cited by 35
Aliu, A., Bosch, D. H. C. A., Keszthelyi, D., Ardabili, A. R., Colombel, J., Sawyer, R., Törnblom, H., Hart, A. L., Jonkers, D. M. A. E., Pierik, M. J., et al. (2024) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.17988 · Cited by 30
“142 Eluxadoline is only approved in the United States.”
BackgroundReplacement of current opioid drugs focusing on MOR-related strategies
Busserolles, J., Lolignier, S., Kerckhove, N., Bertin, C., Authier, N., & Eschalier, A. (2020) · Pharmacology & Therapeutics · doi:10.1016/j.pharmthera.2020.107519 · Cited by 36
“In phase III studies, it reduced abdominal pain, significantly vs placebo (Brenner et al., 2019; Lacy et al., 2019; Lembo et al., 2016).”
BackgroundPannemans, J., & Corsetti, M. (2018) · Current opinion in pharmacology (Print) · doi:10.1016/j.coph.2018.08.008 · Cited by 27
Sultan, S., & Malhotra, A. (2017) · Annals of Internal Medicine · doi:10.7326/aitc201706060 · Cited by 27
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“2%), one with eluxadoline 75mg and one with eluxadoline 100mg (Lembo et al., 2016).”
BackgroundSelf-citationQuigley, E., Markinson, L., Stevenson, A., Treasure, F., & Lacy, B. E. (2022) · Alimentary Pharmacology and Therapeutics · doi:10.1111/apt.17310 · Cited by 26
Self-citationChedid, V. G., Vijayvargiya, P., & Camilleri, M. (2017) · Clinical Gastroenterology and Hepatology · doi:10.1016/j.cgh.2017.11.025 · Cited by 26
“There was significant improvement in the composite endpoint of abdominal pain and stool consistency with eluxadoline compared to placebo, but no improvement in abdominal pain alone(11).”
InfluentialCash, B. D., Pimentel, M., Rao, S. S. C., Weinstock, L. B., Chang, L., Heimanson, Z., & Lembo, A. J. (2017) · Therapeutic Advances in Gastroenterology · doi:10.1177/1756283x17726087 · Cited by 31
Self-citationRisk of Pancreatitis Following Treatment of Irritable Bowel Syndrome With Eluxadoline
Gawron, A., & Bielefeldt, K. (2017) · Clinical Gastroenterology and Hepatology · doi:10.1016/j.cgh.2017.08.006 · Cited by 26
Eluxadoline in irritable bowel syndrome with diarrhea: rationale, evidence and place in therapy
Barshop, K., & Staller, K. (2017) · Therapeutic Advances in Chronic Disease · doi:10.1177/2040622317714389 · Cited by 25
Dothel, G., Chang, L., Shih, W., Barbaro, M. R., Cremon, C., Stanghellini, V., Ponti, F. D., Mayer, E. A., Barbara, G., & Sternini, C. (2019) · Neurogastroenterology & Motility · doi:10.1111/nmo.13688 · Cited by 30
Rawla, P., Sunkara, T., & Raj, J. P. (2018) · Life Science · doi:10.1016/j.lfs.2018.10.001 · Cited by 25
The Delta Opioid Receptor in Pain Control.
Abdallah, K., & Gendron, L. (2018) · Handbook of Experimental Pharmacology · doi:10.1007/164_2017_32 · Cited by 25
Metadata
- Authors
- Lembo, A. J., Lacy, B. E., Zuckerman, M. J., Schey, R., Dove, L. S., Andrae, D. A., Davenport, J. M., McIntyre, G., Lopez, R., Turner, L., & Covington, P. S.
- Affiliations
- Dartmouth College (US)
- Texas Tech University Health Sciences Center (US)
- Temple University (US)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2016-01-21
- Volume
- 374
- Issue
- 3
- Pages
- 242-253
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2330377679
- Cited by
- 334
- References
- 0
- Citations by year
- 2026: 21 · 2025: 23 · 2024: 23 · 2023: 19 · 2022: 27 · 2021: 40 · 2020: 31 · 2019: 31 · 2018: 41 · 2017: 49 · 2016: 27
- FWCI
- 54.37
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Infant Health and Development
- Health Sciences › Medicine › Gastroenterology › Inflammatory Bowel Disease
- Keywords
- eluxadoline, irritable bowel syndrome with diarrhea, mu-opioid receptor agonists, kappa opioid receptor agonists, delta-opioid receptor antagonists, abdominal pain, stool consistency, drug safety and efficacy, nausea, constipation, adverse events, dose comparison
- MeSH terms
- Adult, Aged, Diarrhea, Dose-Response Relationship, Drug, Female, Humans, Imidazoles, Male, Middle Aged, Pancreatitis, Phenylalanine, Abdominal Pain, Irritable Bowel Syndrome
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