Methods for treating irritable bowel syndrome (IBS)
Inventors
Forbes, William • Bortey, Enoch
Assignees
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Publication Number
US-10765667-B2
Publication Date
2020-09-08
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
A method of treating one or more symptoms of irritable bowel syndrome (IBS) in a subject 65 years of age or older is described, comprising administering 550 mg of rifaximin TID for 14 days to treat one or more IBS symptoms in the subject 65 years of age or older. The approach is grounded in treating specific IBS symptom sets, including cramping, pain, diarrhea, constipation, lumpy stool, watery stool, frequent stool production, abdominal pain, abdominal discomfort, and urgency. The treatment effect is defined using symptom reduction relative to baseline symptoms and/or subject-reported affirmative responses.
A method of treating bloating associated with diarrhea-predominant IBS in a subject 65 years old or older is also described, comprising administering 550 mg of rifaximin TID for 14 days to treat bloating associated with diarrhea-predominant IBS. The reduction in bloating is defined as a reduction compared with baseline symptoms established prior to treatment, and/or as an affirmative response from the subject when asked whether they have had a reduction in bloating. In additional embodiments, timing constraints require that the reduction is achieved following 7 days after the administration of rifaximin.
The disclosed clinical evidence supports durable symptom outcomes, including adequate relief endpoints over treatment and follow-up and quality of life improvements using IBS-QOL questionnaire domains. The document also links baseline severity and durability of response after stopping rifaximin, including analyses of response durability. Mechanistically, rifaximin is described as inhibiting a bacterial RNA polymerase beta-subunit.
Claims Coverage
Two independent claims are identified (methods using rifaximin in subjects 65 years of age or older). The inventive features focus on an age-restricted rifaximin regimen and defined outcomes for IBS symptoms and bloating, including how response is determined (baseline-relative and/or subject affirmative responses) and when it is achieved (including a 7-day timing constraint).
Age-restricted rifaximin regimen for IBS symptom treatment
Treating one or more symptoms of irritable bowel syndrome (IBS) in a subject 65 years of age or older by administering 550 mg of rifaximin TID for 14 days.
Defined bloating treatment associated with diarrhea-predominant IBS
Treating bloating associated with diarrhea-predominant IBS in a subject 65 years old or older by administering 550 mg of rifaximin TID for 14 days to treat bloating associated with diarrhea-predominant IBS.
Response definition relative to baseline and/or subject affirmative responses
Defining treatment as reduction of one or more IBS symptoms and/or reduction of bloating as compared with baseline symptoms established prior to treatment, and/or as an affirmative response from the subject when asked whether they have had a reduction in symptoms of IBS or a reduction in bloating.
Time-to-effect constraint for symptom reduction after rifaximin
Requiring that the reduction of the one or more symptoms and/or the reduction in bloating is achieved following 7 days after the administration of rifaximin.
The claim set centers on rifaximin dosing (550 mg TID for 14 days) in subjects aged 65 years or older, with outcome definitions based on baseline-relative symptom reduction and/or subject affirmative responses, and with embodiments requiring that reduction is achieved following 7 days after rifaximin administration. Coverage includes IBS symptom treatment and bloating associated with diarrhea-predominant IBS.
Stated Advantages
Durable symptom outcomes, including adequate relief endpoints over treatment and follow-up.
Quality of life improvements using IBS-QOL questionnaire domains.
Documented Applications
Treating one or more symptoms of irritable bowel syndrome (IBS) in a subject 65 years of age or older using rifaximin 550 mg TID for 14 days.
Treating bloating associated with diarrhea-predominant IBS in a subject 65 years old or older using rifaximin 550 mg TID for 14 days.
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