Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 12-Week, Placebo-Controlled Phase 3 Trial (T3MPO-1).

"CONFLICTS OF INTEREST Guarantor of the article: William D. Chey, MD, AGAF, FACG, FACP, RFF. Specific author contributions: W.D.C. and A.J.L. contributed to the planning of the study, interpretation of the data, and critical revision of the manuscript for important intellectual content; D.P.R. contributed to the planning of the study, conduct of the study, interpretation of the data, and critical revision of the manuscript for important intellectual content; all authors approved the final version of the manuscript for submission. Financial support: Medical writing support was provided by Svetha Sankar, BSc BVMS, and Steven Inglis, PhD, of Oxford PharmaGenesis and was funded by Ardelyx. Potential competing interests: W.D.C. is a consultant for Allergan, Biomerica, IM Health, Ironwood, Outpost, Prometheus, QOL Medical, Ritter Pharmaceuticals, and Salix/Valeant and has received research funding from Ardelyx, Biomerica, Commonwealth Diagnostics International, Ironwood, Nestlé, QOL Medical, Salix/Valeant, Vibrant, and Zespri. A.J.L. is a consultant for Allergan, Ardelyx, Bioamerica, Ironwood, Prometheus, and Valeant and has received research funding from Prometheus, Bioamerica, Vibrant, and Ironwood. D.P.R. is an employee of, and has ownership interest in, Ardelyx, Inc.Study HighlightsWHAT IS KNOWN✓ There are few treatment options for constipation-predominant IBS that effectively improve abdominal symptoms.✓ In a phase 2b study, tenapanor improved CSBM frequency and abdominal pain rates in the same week (“combined response”) for ≥6 of 12 weeks, relative to placebo.WHAT IS NEW HERE✓ Consistent with the phase 2b study, tenapanor treatment improved the combined response rate for ≥6 of 12 weeks, relative to placebo.✓ Tenapanor improved combined response rates for ≥9 of 12 weeks, including ≥3 of the final 4 treatment weeks, compared with placebo.✓ Improvement from baseline in CSBMs per week was sustained to week 16 of tenapanor treatment.✓ Tenapanor was generally well tolerated for up to 16 weeks; the most common AE was diarrhea."

"Financial support: Medical writing support was provided by Svetha Sankar, BSc BVMS, and Steven Inglis, PhD, of Oxford PharmaGenesis and was funded by Ardelyx."

"This study (T3MPO-1; ClinicalTrials.gov identifier NCT02621892) was conducted in accordance with the Declaration of Helsinki. All participating sites obtained independent ethics committee/institutional review board approval, and all patients provided written informed consent before their participation in the trial."