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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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Post-marketing reports of pancreatitis in eluxadoline-treated patients pre and post US label change
Cash, B. D., Lacy, B. E., Watton, C., Schoenfeld, P., & Weissman, D. (2021) · Therapeutic Advances in Gastroenterology · doi:10.1177/17562848211001725 · Cited by 8
Self-citationLembo, A., Covington, P., Dove, L. S., & Andrae, D. (2020) · Neurogastroenterology and Motility · doi:10.1111/nmo.13774 · Cited by 6
Self-citationLior, O., Sklerovsy-Benjaminov, F., Lish, I., Konokoff, F., & Naftali, T. (2019) · The Journal of Bioscience and Medicine · doi:10.4236/jbm.2019.75018 · Cited by 6
“Treatment options might include non-medical approaches such as dietary modifications, change in lifestyle and cognitive behavior therapy [4] medical approaches include drugs such as laxatives, lubiproston [5] linaclotide, antidiarrheals, alosetron, rifaximin [6], and eluxadoline [7].”
BackgroundCorsetti, M., Pannemans, J., & Whorwell, P. (2019) · F1000Research · doi:10.12688/f1000research.15974.1 · Cited by 6
Inflammatory Bowel Disease and Irritable Bowel Syndrome: What to Do When There Is an Overlap
Kamal, A., Padival, R., & Lashner, B. A. (2018) · Inflammatory Bowel Diseases · doi:10.1093/ibd/izy277 · Cited by 8
Brenner, D. M., Dove, L. S., Andrae, D. A., Covington, P. S., Gutman, C. R., & Chey, W. D. (2018) · Neurogastroenterology & Motility · doi:10.1111/nmo.13331 · Cited by 5
“…defined as daily improvement of ≥30%, ≥40%, or ≥50% in worst abdominal pain score vs average baseline pain on ≥50% of treatment days. aData reported in Lembo et al. 2016.17 0 10 20 30 40 50 60 Composite endpointa Stool consistency ≥75% urgencyfree days ≥50% urgencyfree days Adequate relief Pain…”
BackgroundInfluentialSelf-citationVitta, S., & Sayuk, G. (2018) · Alimentary Pharmacology and Therapeutics · doi:10.1111/apt.14902 · Cited by 6
“4).(4,5) Though methodologically sound, this study does deviate from current European and US endpoint guidance for IBS-D trials (requiring combined abdominal pain and stool consistency improvements) and study duration.”
ResultZheng, Y., Obeng, S., Wang, H., Stevens, D. L., Komla, E., Selley, D. E., Dewey, W. L., Akbarali, H. I., & Zhang, Y. (2018) · ACS Chemical Neuroscience · doi:10.1021/acschemneuro.8b00234 · Cited by 6
New therapies in Irritable Bowel Syndrome: what works and when
Craig, O. (2018) · Current Opinion in Gastroenterology · doi:10.1097/mog.0000000000000411 · Cited by 6
Imidazoles in medicine: a review of its pharmacological and therapeutic applications
K., N., & Jayamoorthy, K. (2026) · Phosphorus Sulfur and Silicon and the Related Elements · doi:10.1080/10426507.2025.2611018 · Cited by 5
“Eluxadoline, [113,114] originally developed by Janssen and now marketed by Allergan (formerly Actavis) under the trade name Viberzi, received FDA approval in May 2015 for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D).”
Akyuz, F., Çelebi, A., Dogan, I., Erzin, Y., Kav, T., Soytürk, M., Oğuz, D., Özer, B., & Kaymakoğlu, S. (2024) · The Turkish Journal of Gastroenterology · doi:10.5152/tjg.2024.24029 · Cited by 5
Anderle, K., Wolzt, M., Moser, G., Keip, B., Peter, J., Meisslitzer, C., Gouya, G., Freissmuth, M., & Tschegg, C. (2022) · World Journal of Gastroenterology · doi:10.3748/wjg.v28.i46.6573 · Cited by 5
Vijayvargiya, P., Breen-Lyles, M., Nord, S. L., Maselli, D. B., Busciglio, I., Boinpally, R., Muslin, A., Carrothers, T. J., & Camilleri, M. (2022) · Digestive Diseases and Sciences · doi:10.1007/s10620-022-07379-x · Cited by 5
“1 3 The duration of treatment was chosen to be consistent with clinical practice in IBS, where a 1-month therapeutic study of a new agent is common, and was supported by results of the phase 3 studies which showed that a patient’s response to eluxadoline treatment over the first month was reasonably predictive of resp…”
BackgroundResultInfluentialEfficacy of glutamine in postinfection IBS
Ford, A., & Gibson, P. (2018) · Gut · doi:10.1136/gutjnl-2018-317438 · Cited by 5
The place of eluxadoline in the management of irritable bowel syndrome with diarrhea
Levio, S., & Cash, B. D. (2017) · Therapeutic Advances in Gastroenterology · doi:10.1177/1756283x17721152 · Cited by 6
Current Landscape of Novel Therapeutic Agents and Drug Targets in Irritable Bowel Syndrome
Joshi, D. C., Raina, N., Joshi, N., Gurow, K., Gwasakoti, J., Sood, A., Mehrotra, A., Tuli, H. S., Paudel, K. R., & Gupta, M. (2025) · Archiv der Pharmazie · doi:10.1002/ardp.70133 · Cited by 4
All in my head or all in my gut? An update on irritable bowel syndrome.
Woods, A., Ford, A. C., & Black, C. (2025) · Current Opinion in Gastroenterology · doi:10.1097/mog.0000000000001141 · Cited by 4
Jafari, S., Atmani, A., Gohari, S., & Seifi, E. (2024) · Middle East Journal of Digestive Diseases · doi:10.34172/mejdd.2024.386 · Cited by 4
Treatment and Management of Gastrointestinal Disorders
Montgomery, G., Patel, A., & Pfeil, S. A. (2024) · Medical Clinics of North America · doi:10.1016/j.mcna.2024.03.010 · Cited by 4
Irritable bowel syndrome – less irritable, or better treatments?
Travers, P., Lacy, B. E., & Cangemi, D. J. (2023) · Current Opinion in Gastroenterology · doi:10.1097/mog.0000000000000987 · Cited by 4
Self-citationPharmacological approaches to treat intestinal pain
Świerczyński, M., Makaro, A., Grochowska, A., & Sałaga, M. (2023) · Expert Review of Clinical Pharmacology · doi:10.1080/17512433.2023.2195626 · Cited by 6
“other research did not present the significant change in pain score in such dose [37].”
ResultBajaj, J. S., Brenner, D. M., Cai, Q., Cash, B. D., Crowell, M. D., DiBaise, J. K., Gallegos-Orozco, J. F., Gardner, T. B., Gyawali, C. P., Ha, C. Y., et al. (2020) · The American Journal of Gastroenterology · doi:10.14309/ajg.0000000000000709 · Cited by 6
Self-citationMunjal, A., Dedania, B., & Cash, B. (2019) · Expert Opinion on Pharmacotherapy · doi:10.1080/14656566.2019.1691524 · Cited by 4
Dodda, S., Makula, A., Polagani, S. R., & Kandhagatla, R. (2019) · Journal of Pharmaceutical and Biomedical Analysis · doi:10.1016/j.jpba.2018.11.056 · Cited by 4
Almario, C. V., Noah, B. D., Jusufagic, A., Lew, D., & Spiegel, B. M. R. (2018) · Clinical Gastroenterology and Hepatology · doi:10.1016/j.cgh.2018.03.025 · Cited by 7
Eluxadoline: a promising therapy that raises many questions
Cash, B. D. (2016) · Translational Gastroenterology and Hepatology · doi:10.21037/tgh.2016.09.06 · Cited by 5
“Lembo and colleagues recently reported the results of the phase 3 registration trials (IBS-3001 and IBS-3002) that supported FDA approval of eluxadoline in the January 21, 2016 issue of the New England Journal of Medicine (3).”
BackgroundResultInfluentialThe interactions between gut and brain in gastrointestinal disorders
Blaga, T. S., Dumitrascu, D. L., Pop, A., & Grad, S. (2021) · Elsevier eBooks · doi:10.1016/b978-0-12-821927-0.00008-5 · Cited by 5
Balakumar, P., Mulukuri, N. V. L. S., & Jagadeesh, G. (2025) · Pharmacology & Therapeutics · doi:10.1016/j.pharmthera.2025.108945 · Cited by 5
Kerbage, A., Loesch, J., Hamza, E., Khan, S., Nero, N., Simons, M. L., & Lembo, A. J. (2024) · American Journal of Gastroenterology · doi:10.14309/ajg.0000000000003099 · Cited by 3
Self-citationPrimer consenso centroamericano y del Caribe del síndrome de intestino irritable
Estrada, J. G., Aguilar-Paiz, L., Blanco, G., Monge, S. C., Cantillo, L. D. M., Castillo, P. N., Quintero, I., Polanco, E. D. P. R., Hernández, M. A. S., Sandoval, E., et al. (2023) · Acta gastroenterologica Latinoamericana · doi:10.52787/agl.v53i2.272 · Cited by 3
The Involvement of the Endogenous Opioid System in the Gastrointestinal Aging in Mice and Humans
Szymaszkiewicz, A., Talar, M., Włodarczyk, J., Świerczyński, M., Bartoszek, A., Krajewska, J., Mokrowiecka, A., Małecka-Wojciesko, E., Fichna, J., & Zielińska, M. (2022) · International Journal of Molecular Sciences · doi:10.3390/ijms23073565 · Cited by 3
“, eluxadoline (a mixed ligand of ORs, a drug approved for diarrhea-predominant irritable bowel syndrome (IBS-D) [10]), loperamide (a MOP agonist, applied in acute diarrhea; with limited application in IBS-D [11]), trimebutine (MOP, DOP, KOP agonist; applied in IBS [12]), methylnaltrexone (antagonist of peripheral MOP…”
BackgroundSzymaszkiewicz, A., Włodarczyk, J., Mazur, M., Olczak, J., Fichna, J., & Zielińska, M. (2020) · Pharmacological Reports · doi:10.1007/s43440-020-00084-4 · Cited by 3
“1% in the placebo group experienced nausea [20].”
BackgroundFeng, B. (2020) · Cellular and Molecular Gastroenterology and Hepatology · doi:10.1016/j.jcmgh.2020.01.001 · Cited by 3
“Eluxadoline was approved in the United States in 2015 to alleviate symptoms in patients with diarrhea-predominant IBS, including visceral pain.(3) Despite the clinical success of eluxadoline, several fundamental questions regarding the interaction between the MORs and DORs in the ENS remain unresolved.”
Background
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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