IP Library Granted Patent US 9,980,938
Granted Patent B2
US 9,980,938 · App. 14/466,089 · Granted May 29, 2018

Method for treatment of diarrhea-predominant irritable bowel syndrome

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Quick Facts
Patent No.
US 9,980,938
App. No.
14/466,089
Granted
May 29, 2018
Kind
B2
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.

Claims (18)

1. A method of treating a patient having pain associated with diarrhea-predominant irritable bowel syndrome (d-IBS), comprising 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.

2. The method of claim 1 , wherein the proanthocyanidin polymer is crofelemer.

3. The method of claim 1 , wherein the composition is orally administered.

4. The method of claim 3 , wherein the proanthocyanidin polymer is crofelemer.

5. The method of claim 4 , wherein crofelemer is enteric coated.

6. The method of claim 5 , wherein crofelemer is administered to the patient at about 250 mg per day.

7. The method of claim 5 , wherein crofelemer is administered to the patient at about 125 mg twice daily.

8. The method of claim 1 , wherein the amount of the proanthocyanidin polymer is bioequivalent to crofelemer at a dosage of about 250 mg per day.

9. The method of claim 1 , wherein the amount of the proanthocyanidin polymer is bioequivalent to crofelemer at a dosage of about 125 mg twice daily.

10. The method of claim 1 , wherein the number of pain-free days are increased by at least 10% after administration of the composition.

11. The method of claim 1 , wherein the average level of pain as measured by a pain score is decreased after administration of the composition.

12. The method of claim 1 , wherein the number of days free of the urgency for stool passage is increased after administration of the composition, wherein said urgency is associated with d-IBS.

13. The method of claim 1 , wherein the patient is a human female.

14. The method of claim 1 , wherein the composition is administered twice daily.

15. 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.

16. The method of claim 15 , wherein the daily stool frequency is also decreased after administration of the composition.

17. The method of claim 15 , wherein the crofelemer is administered to the patient at about 125 mg twice a day.

18. The method of claim 15 , wherein the composition is administered twice daily.

Assignments (4)
SECURITY INTEREST Recorded Nov 22, 2017
From: NAPO PHARMACEUTICALS, INC.
To: KINGDON CAPITAL MANAGEMENT, L.L.C.
Reel/Frame 044497/0954 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 9, 2015
From: QUART, BARRY D.
To: NAPO PHARMACEUTICALS, INC.
Reel/Frame 035365/0939 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 9, 2015
From: ROSENBAUM, DAVID P.; NEENAN, THOMAS X.; BLANKS, ROBERT C.
To: TRINE PHARMACEUTICALS, INC.
Reel/Frame 035369/0380 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 9, 2015
From: TRINE PHARMACEUTICALS, INC.
To: NAPO PHARMACEUTICALS, INC.
Reel/Frame 035369/0970 →