Efficacy and Safety of Eluxadoline in Patients With Irritable Bowel Syndrome With Diarrhea Who Report Inadequate Symptom Control With Loperamide: RELIEF Phase 4 Study.

"CONFLICTS OF INTEREST Guarantor of the article: Darren M. Brenner, MD. Specific author contributions: D.M.B., C.R.G., and E.J. contributed to the study concept and design. D.M.B. and L.W.C.L. were principal investigators and supervised study-related activities at respective study sites. D.M.B., G.S.S., C.R.G., S.J.R.E., L.W.C.L., and B.D.C. contributed to the analysis and interpretation of data. All authors contributed to the drafting, critical revision for intellectual content, and final approval of the manuscript. Financial support: This study was sponsored by Allergan plc, Dublin, Ireland. Writing and editorial assistance was provided to the authors by Germaine D. Agollah, PhD of Allergan plc and editorial assistance was also provided by Complete HealthVizion, Chicago, IL, USA. All authors met the ICMJE authorship criteria. Neither honoraria nor payments were made for authorship. Potential competing interests: Financial arrangements of the authors with companies whose products may be related to the present report are listed below, as declared by the authors. D.M.B. and G.S.S. are both consultants and speakers for Allergan plc and Ironwood Pharmaceuticals. C.R.G., E.J., and S.J.R.E. are full-time employees of Allergan plc and may own company stock. L.W.C.L. has received honoraria from Allergan, Lupin, Medtronic, AbbVie, and Takeda as a consultant and speaker, from Knight and Pendopharm as a speaker, and from Cipher as a consultant. B.D.C. has served as an advisor, consultant, or speaker for Allergan plc, Salix Pharmaceuticals, Takeda Pharmaceuticals, and Ironwood Pharmaceuticals. Study HighlightsWHAT IS KNOWN✓ Eluxadoline is an FDA-approved therapy for the treatment of IBS-D.✓ In post-hoc analyses of phase 3 clinical trials, patients failing to experience improvements in their IBS symptoms from loperamide appeared to derive symptomatic benefits from eluxadoline.WHAT IS NEW HERE✓ Eluxadoline improves IBS-D symptoms in individuals subjectively reporting inadequate responses to loperamide.✓ Eluxadoline improves both pain and bowel functions in individuals reporting inadequate responses to loperamide.✓ In a population of individuals with IBS-D with an intact gallbladder, no events of sphincter of Oddi spasm or pancreatitis occurred while taking eluxadoline."

"Financial support: This study was sponsored by Allergan plc, Dublin, Ireland. Writing and editorial assistance was provided to the authors by Germaine D. Agollah, PhD of Allergan plc and editorial assistance was also provided by Complete HealthVizion, Chicago, IL, USA. All authors met the ICMJE authorship criteria. Neither honoraria nor payments were made for authorship."