Method for treatment of diarrhea-predominant irritable bowel syndrome
Inventors
Quart, Barry D. • Rosenbaum, David • Neenan, Thomas • Blanks, Robert C.
Assignees
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Publication Number
US-9980938-B2
Publication Date
2018-05-29
Expiration Date
Abstract
The present invention provides methods for treating diarrhea-predominant irritable bowel syndrome comprising administering to a patient in need thereof, an inhibitor of chloride-ion transport in an amount sufficient to treat diarrhea-predominant irritable bowel syndrome (d-IBS). Treatment of d-IBS includes the treatment of the diarrhea component of d-IBS as well as the pain, abdominal discomfort and other symptoms associated with d-IBS. In one embodiment, the inhibitor of chloride-ion transport is crofelemer.
Core Innovation
The invention relates to a method of treating a patient having pain associated with diarrhea-predominant irritable bowel syndrome (d-IBS) by administering to the patient a composition comprising a proanthocyanidin polymer derived from C. lechleri in an amount bioequivalent to crofelemer within a specified daily dosage range. The treatment is directed to symptoms associated with d-IBS, including pain and other related manifestations described in the document.
The invention further relates to a method of treating a patient having urgency for stool passage associated with d-IBS by orally administering enterically coated crofelemer in an amount effective to reduce urgency for stool passage associated with d-IBS. The enterically coated composition is administered within a specified daily dosage range, and the document describes treatment endpoints focused on urgency and other stool-related outcomes.
The document addresses a problem in which diarrhea-predominant irritable bowel syndrome is associated with pain and with urgency for stool passage, and in which chloride-ion transport and CFTR-mediated chloride transport are described as involved. By using crofelemer, the document states that treatment alleviates symptoms of d-IBS, including pain and urgency for stool passage, and it provides study results and mechanism investigations consistent with the treatment effects described.
Claims Coverage
The partial content provides two independent claims (one for treating pain associated with d-IBS and one for treating urgency for stool passage associated with d-IBS). Across these claims, the inventive features focus on using a C. lechleri-derived proanthocyanidin polymer (crofelemer) and, in the urgency claim, administering an enterically coated crofelemer composition by an oral route within specified daily dosage ranges to reduce the relevant symptom(s).
Proanthocyanidin polymer treatment of pain associated with d-IBS
A method of treating a patient having pain associated with diarrhea-predominant irritable bowel syndrome (d-IBS) by administering to the patient a composition comprising a proanthocyanidin polymer derived from C. lechleri in an amount bioequivalent to crofelemer at a dosage of about 100 mg per day to about 300 mg per day.
Enterically coated crofelemer to reduce urgency associated with d-IBS
A method of treating a patient having urgency for stool passage associated with diarrhea-predominant irritable bowel syndrome (d-IBS) comprising orally administering to the patient a composition comprising enterically coated crofelemer in an amount effective to reduce urgency for stool passage associated with d-IBS, wherein crofelemer is administered to the patient at about 200 mg per day to about 300 mg per day.
The independent claim set covers crofelemer/proanthocyanidin-polymer-based treatment for (i) pain associated with d-IBS within about 100 mg/day to about 300 mg/day, and (ii) urgency for stool passage associated with d-IBS using orally administered enterically coated crofelemer within about 200 mg/day to about 300 mg/day.
Stated Advantages
Alleviates diarrhea-predominant irritable bowel syndrome symptoms, including pain.
Reduces urgency for stool passage associated with diarrhea-predominant irritable bowel syndrome.
Increases pain-free days and provides reductions in pain score as reported in the Phase 2 randomized double-blind placebo-controlled study.
Increases urgency-free days for stool passage as reported in the Phase 2 randomized double-blind placebo-controlled study.
Documented Applications
Treatment of a patient having pain associated with diarrhea-predominant irritable bowel syndrome (d-IBS) using a composition comprising a proanthocyanidin polymer derived from C. lechleri bioequivalent to crofelemer within the stated daily dosage range.
Treatment of a patient having urgency for stool passage associated with diarrhea-predominant irritable bowel syndrome (d-IBS) using orally administered enterically coated crofelemer within the stated daily dosage range.
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