Methods for treating irritable bowel syndrome (IBS)
Inventors
Forbes, William • Bortey, Enoch
Assignees
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Publication Number
US-11779571-B2
Publication Date
2023-10-10
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 document describes rifaximin/rifamycin-class treatment methods and kits for bowel diseases, with emphasis on diarrhea-predominant irritable bowel syndrome (dIBS/IBS-D) and bloating. A problem addressed is providing a durable symptom response, including response that persists after discontinuation of treatment. The approach includes administering a therapeutically effective amount of rifaximin to treat symptoms associated with dIBS.
The document further describes patient-selection approaches for identifying individuals likely to respond, including responding after 1–24 weeks of treatment and predictors based on gender, age, disease duration, and baseline severity. It also discloses optional genetic risk profiling using polymorphisms, including Nod2, CFTR, CARD15, and polymorphisms identified as rs6822844, rs2305767, and rs6983267, along with additional markers listed in the document. The response is defined using subject-reported affirmative response for adequate relief of IBS symptoms and adequate relief of bloating compared to baseline symptoms.
The document includes supporting clinical-study results showing statistically significant improvements versus placebo for IBS symptoms and bloating, including subgroup effects such as male versus female, age groups, non-white, and IBS subtype. Treatment regimens and dosing are described, including 550 mg rifaximin TID for 14 days, alternative dosing including 550 mg rifaximin BID and dosing described as 1650 mg/day. The document also includes compound and formulation background, including rifaximin structures/formulae and rifaximin polymorphs/forms, and a pharmacologic rationale including low systemic absorption and inhibition of bacterial RNA polymerase.
Claims Coverage
The partial content provided includes one independent claim, with several dependent claims refining the method by defining the reduction of bloating relative to baseline, adding a timing condition after 7 days, and defining the reduction as an affirmative subject-reported response.
Treating bloating associated with diarrhea-predominant irritable bowel syndrome in a female subject
Administering 550 mg of rifaximin TID for 14 days to the female subject to treat bloating associated with diarrhea-predominant irritable bowel syndrome (dIBS) in the female subject.
Reducing bloating relative to baseline symptoms
Treating bloating comprising a reduction of bloating from baseline symptoms established prior to treatment.
Timing of bloating reduction after 7 days
The reduction of bloating is achieved following 7 days after the administration of rifaximin.
Affirmative subject-reported bloating reduction
The reduction of bloating comprises an affirmative response from the subject when asked whether they had a reduction in bloating.
Across the independent claim and its dependent refinements, the claims focus on administering rifaximin to a female subject for dIBS-associated bloating, with the bloating treatment effect characterized as a reduction from baseline, occurring after a specified time point, and defined by an affirmative subject-reported response.
Stated Advantages
Statistically significant improvements versus placebo for IBS symptoms.
Statistically significant improvements versus placebo for bloating.
Durability of symptom response after discontinuation of treatment.
Documented Applications
Treating bloating associated with diarrhea-predominant irritable bowel syndrome (dIBS/IBS-D) in a female subject using rifaximin.
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