# US 10,765,667 B2 · Methods for treating irritable bowel syndrome (IBS)

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- Number: US 10,765,667 B2
- Document ID: US10765667B2
- Status: Granted
- Kind: B2
- Application number: 16/738,392
- Filed: 2020-01-09
- Published: 2020-07-02
- Granted: 2020-09-08
- Earliest claimed: 2008-02-26
- Assignees: Salix Pharmaceuticals, Inc.
- Applicants: Salix Pharmaceuticals, Inc.
- Inventors: William Forbes; Enoch Bortey
- Web page: https://patentgrep.com/patent/US10765667B2

## CPC

- A61K 31/437: the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 1/06: Anti-spasmodics, e.g. drugs for colics, esophagic dyskinesia
- A61P 1/10: Laxatives
- A61P 1/12: Antidiarrhoeals
- A61P 29/02: without antiinflammatory effect
- A61P 31/04: Antibacterial agents
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## 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.

## Claims

### Claim 1

A method of treating one or more symptoms of irritable bowel syndrome (IBS) in a subject 65 years of age or older, said method comprising administering, 550 mg of rifaximin TID for 14 days to the subject, thereby treating one or more symptoms of IBS in the subject 65 years of age or older.

### Claim 2 (depends on 1)

The method of claim 1, wherein the one or more symptoms are selected from one or more of cramping, pain, diarrhea, constipation, lumpy stool, watery stool, frequent stool production, abdominal pain, abdominal discomfort, and urgency.

### Claim 3 (depends on 1)

The method of claim 1, wherein the IBS is diarrhea-predominant IBS.

### Claim 4 (depends on 1)

The method of claim 1, wherein the IBS is alternating IBS.

### Claim 5 (depends on 1)

The method of claim 1, wherein the treating one or more symptoms of IBS comprises a reduction of the one or more symptoms from baseline symptoms established prior to treatment.

### Claim 6 (depends on 5)

The method of claim 5, wherein the reduction of the one or more symptoms is achieved following 7 days after the administration of rifaximin.

### Claim 7 (depends on 1)

The method of claim 1, wherein treating one or more symptoms of IBS comprises a reduction in symptoms defined by an affirmative response from the subject when asked whether they had a reduction in symptoms of IBS.

### Claim 8

A method of treating bloating associated with diarrhea-predominant IBS in a subject 65 years old or older, said method comprising administering, 550 mg of rifaximin TID for 14 days to the subject, thereby treating bloating associated with diarrhea-predominant IBS in the subject 65 years old or older.

### Claim 9 (depends on 8)

The method of claim 8, wherein the treating of bloating comprises a reduction of bloating.

### Claim 10 (depends on 9)

The method of claim 9, wherein the reduction of bloating is achieved following 7 days of the administration of the rifaximin.

### Claim 11 (depends on 9)

The method of claim 9, wherein the reduction of bloating comprises an affirmative response from a subject if asked whether they have had a reduction in bloating.

### Claim 12 (depends on 8)

The method of claim 8, further comprising treating one or more symptoms associated with diarrhea-predominant IBS selected from cramping, pain, diarrhea, constipation, lumpy stool, watery stool, frequent stool production, abdominal pain, abdominal discomfort, urgency, and tenesmus.

### Claim 13 (depends on 9)

The method of claim 9, wherein the reduction in bloating is a reduction as compared with baseline.

### Claim 14 (depends on 13)

The method of claim 13, wherein baseline is established prior to treatment.

### Claim 15 (depends on 14)

The method of claim 14, wherein the reduction in bloating is achieved following 7 days of the administration of the rifaximin.

### Claim 16 (depends on 15)

The method of claim 15, wherein the reduction in bloating comprises an affirmative response from a subject if asked whether they have had a reduction in bloating.