Methods and compositions for treating bile acid diarrhea, diarrhea associated with small intestine resection or gallbladder removal, and short bowel syndrome

A technology of syndrome and composition, applied in the field of proanthocyanidin polymer composition, capable of solving problems such as unmet clinical needs

Pending Publication Date: 2020-02-21
NAPO PHARMA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] Diarrhea associated with bile acid diarrhea, small bowel resection, cholecystectomy, and SBS therefore represents an important and unmet clinical need for more effective management

Method used

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  • Methods and compositions for treating bile acid diarrhea, diarrhea associated with small intestine resection or gallbladder removal, and short bowel syndrome

Examples

Experimental program
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Effect test

Embodiment 1

[0139] A 67-year-old female patient presented with an unresectable desmoid tumor in the retroperitoneum that invaded the mesentery of the colon and small intestine. This requires the formation of a small enterostomy, which causes SBS to occur.

[0140] As a result, the patient suffers from chronic diarrhea. For 12 years, the patient had tried loperamide, diphenoxylate, and / or atropine, codeine, or opium tinctures for diarrhea. None of them were effective in alleviating her symptoms.

[0141] The patient started crofelemer at 125 mg BID and her symptoms improved. The patient continued to take crofelemer at 125 mg BID for one year and obtained the same level of efficacy. One year later, the patient stopped taking crofelemer for a short time, and the diarrhea symptoms recurred.

Embodiment 2

[0143] A 57-year-old female patient underwent laparoscopic cholecystectomy and developed watery diarrhea immediately after the operation, with about 10-12 episodes of watery diarrhea per week. Taking probiotics and OTC antidiarrheal medicines does not work.

[0144] Approximately 3 years after surgery, the patient was started on crofelemer as she was still experiencing watery diarrhea at a frequency of approximately 10-12 watery diarrhea per week. The patient received 125 mg BID of crofelemer for several weeks until bowel movements returned to normal and then started taking 125 mg of crofelemer daily. During the first 6 weeks of 125 mg crofelemer daily, patients reported normal bowel movements and no episodes of diarrhea.

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Abstract

Presented herein are methods for treating bile acid diarrhea, short bowel syndrome (SBS), and cholecystectomy-associated diarrhea by administering to a patient in need thereof, an inhibitor of chloride-ion transport in an amount sufficient to treat diarrhea. In particular embodiments, infants, and juveniles with SBS are treated with an inhibitor of chloride-ion transport in an amount sufficient totreat 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 ofchloride-ion transport is crofelemer.

Description

technical field [0001] The present invention relates to the prevention, amelioration and / or treatment of bile acid diarrhea or secretory diarrhea associated with short bowel syndrome (SBS) or cholecystectomy using proanthocyanidin polymer compositions from C. lechleri, such as crofelemer Methods. Background technique [0002] bile acid diarrhea [0003] Bile acids are synthesized in the liver from cholesterol and transported into the bile ducts in conjugated form. They then accumulate and are stored in the gallbladder, where they flow into the duodenum following meal-stimulated gallbladder contraction. After delivery into the intestinal lumen, the vast majority is absorbed by the distal ileum into the portal circulation and returns to the liver. Bile acids are taken up by specific transport systems in hepatocytes, and they are then secreted into bile. This recirculation process is called enterohepatic circulation. During this recirculation, most bile acids are absorbed ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/47A61K31/353A61P1/12
CPCA61K31/353A61K36/47A61P1/12A61K45/06A61K31/451Y02A50/30A61K2300/00
Inventor L·A·康特P·R·查特维迪C·康特
Owner NAPO PHARMA INC
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