Methods for treating irritable bowel syndrome (IBS)
Inventors
Forbes, William P. • Bortey, Enoch
Assignees
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Publication Number
US-11564912-B2
Publication Date
2023-01-31
Expiration Date
Abstract
The present invention provides new methods and kits for treating IBS; treating IBS in females; treating IBS in older subjects; and treating IBS in non-white subjects.
Core Innovation
The disclosed invention relates to using rifaximin, a rifamycin-class, GI-specific antibiotic, for treating one or more symptoms of irritable bowel syndrome (IBS) in a female subject. It describes administering 550 mg rifaximin TID for 14 days, with treatment of IBS symptoms including abdominal pain and bloating.
The disclosure addresses diarrhea-predominant IBS and alternating-predominant IBS, and defines selection and assessment of subjects using adequate relief concepts based on Weekly Subject Global Assessment (SGA) questions and criteria tied to symptom and baseline reduction. A key feature is durability of response by selecting subjects who respond during an on-treatment period and discontinuing therapy while maintaining symptom relief after treatment removal.
The disclosure reports clinical study results showing statistically significant improvements in IBS symptoms and bloating versus placebo, including maintenance during post-treatment follow-up and subgroup findings. It also includes rifaximin polymorphs/forms and general pharmaceutical formulation approaches, including pharmaceutically acceptable carriers and kits and printed labeling, and presents risk-prediction concepts using clinical/genetic profiling, including polymorphisms in NOD2/CFTR/CARD15 and other markers, to identify subjects likely to respond.
Claims Coverage
The partial content provides one independent claim and multiple dependent refinements. The independent claim covers treating one or more IBS symptoms in a female subject using a specific rifaximin regimen, while the dependent claims refine the symptom types, IBS subtype, and how treatment effect is defined and assessed, including timing relative to administration and subject-reported adequacy of symptom reduction.
Rifaximin regimen for IBS symptom treatment in a female subject
A method of treating one or more symptoms of irritable bowel syndrome (IBS) in a female subject by administering 550 mg of rifaximin TID for 14 days, thereby treating one or more symptoms of IBS in the female subject.
Selected IBS symptom list
The method wherein the one or more symptoms are selected from cramping, pain, diarrhea, constipation, lumpy stool, watery stool, frequent stool production, abdominal pain, abdominal discomfort, and urgency.
Diarrhea-predominant IBS treatment
The method wherein the IBS is diarrhea-predominant irritable bowel syndrome (IBS).
Symptom reduction relative to baseline
The method wherein treating IBS includes reducing one or more IBS symptoms relative to baseline symptoms established before treatment.
Symptom reduction after seven days
The method further provides that symptom reduction occurs following administration of rifaximin after 7 days.
Subject-affirmed symptom reduction when asked
The method further specifies that treating IBS symptoms involves reducing the subject’s symptoms as determined by the subject affirmatively reporting symptom reduction when asked.
Overall claim coverage focuses on a female-subject IBS symptom treatment using rifaximin 550 mg TID for 14 days, refined by specifying IBS symptom categories, diarrhea-predominant IBS, defining treatment effect as reduction versus baseline, constraining when reduction occurs after 7 days, and using an affirmative subject report to determine symptom reduction.
Stated Advantages
Statistically significant improvements in IBS symptoms versus placebo.
Statistically significant improvements in bloating versus placebo.
Maintenance of symptom improvements during post-treatment follow-up.
Documented Applications
Treating one or more symptoms of irritable bowel syndrome (IBS) in female subjects, including diarrhea-predominant and alternating-predominant IBS presentations, with symptoms such as abdominal pain and bloating.
Selecting and assessing subjects using adequate relief defined by Weekly Subject Global Assessment (SGA) to support durability of response and post-treatment maintenance.
Using risk-prediction concepts based on clinical/genetic profiling (including markers such as NOD2/CFTR/CARD15 polymorphisms) to identify subjects likely to respond.
Formulation and product-related approaches involving rifaximin polymorphs/forms and pharmaceutically acceptable carriers, including kits and printed labeling.
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