Methods and compositions for treating chemotherapy-induced diarrhea
Inventors
Assignees
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Publication Number
US-11389424-B2
Publication Date
2022-07-19
Expiration Date
Abstract
Presented herein are methods for treating diarrhea by administering to a patient in need thereof, an inhibitor of chloride-ion transport in an amount sufficient to treat diarrhea. Treatment of diarrhea includes the treatment of the diarrhea as well as the pain, abdominal discomfort and other symptoms associated with diarrhea. In one embodiment, the inhibitor of chloride-ion transport is crofelemer.
Core Innovation
The invention relates to methods and compositions for preventing, ameliorating, and treating chemotherapy-induced diarrhea (CID) in a human subject undergoing chemotherapy. The method includes administering to a subject in need thereof a composition comprising an effective amount of crofelemer to treat CID, where the chemotherapeutic is neratinib.
Crofelemer is described as a chloride-ion transport inhibitor that acts topically in the GI tract via CFTR and related chloride channel modulation or blockade. In some embodiments, crofelemer is administered as an enteric coated oral dosage form, and the document also describes enteric-protected and non-enteric forms.
In embodiments tied to defined chemotherapy settings, the method includes CID treatment in human subjects undergoing chemotherapy for HER positive breast cancer. For example, administering crofelemer at a dose of 125 mg twice per day is described, with chemotherapy comprising neratinib with or without carboplatin.
The disclosed endpoints and evaluation concepts include stool consistency and bowel movement measures, urgency and fecal incontinence, abdominal pain or discomfort, and diarrhea grade changes using Common Toxicity Criteria. The overall problem addressed is chemotherapy-induced diarrhea in human subjects undergoing chemotherapy, with associated symptoms and impacts on tolerability.
Claims Coverage
The partial content includes 2 independent claims. Across these claims, the inventive coverage centers on crofelemer for chemotherapy-induced diarrhea in specific chemotherapy contexts, including a defined dosing regimen and cancer context.
Crofelemer for cid during neratinib chemotherapy
A method of treating chemotherapy-induced diarrhea in a human subject undergoing chemotherapy by administering to a subject in need thereof a composition comprising an effective amount of crofelemer to treat CID, wherein the chemotherapeutic is neratinib.
125 mg twice per day crofelemer for cid in her positive breast cancer receiving neratinib with or without carboplatin
A method of treating CID in a human subject undergoing chemotherapy for HER positive breast cancer by administering a composition comprising crofelemer at a dose of 125 mg twice per day, wherein the chemotherapy is neratinib with or without carboplatin.
The independent claims cover crofelemer-based treatment of chemotherapy-induced diarrhea during neratinib chemotherapy, and specifically cover a defined 125 mg twice per day crofelemer dosing regimen for CID in HER positive breast cancer where chemotherapy is neratinib with or without carboplatin.
Stated Advantages
Reduce diarrhea severity in chemotherapy-induced diarrhea, including diarrhea grade changes according to Common Toxicity Criteria.
Relieve associated pain or abdominal discomfort.
Improve stool consistency, including changes in stool consistency and diarrhea endpoints.
Reduce or improve bowel movement and watery bowel movement measures, including urgency and fecal incontinence.
Help patients tolerate chemotherapy by treating CID in the context of chemotherapy regimens.
Documented Applications
Treating chemotherapy-induced diarrhea in human subjects undergoing chemotherapy where the chemotherapeutic is neratinib.
Treating chemotherapy-induced diarrhea in human subjects undergoing chemotherapy for HER positive breast cancer using a regimen that includes neratinib with or without carboplatin.
Use of crofelemer-containing compositions, including enteric coated or enteric-protected formulations, to manage CID-related symptoms and stool-related endpoints in the described chemotherapy contexts.
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