IP Library Granted Patent US 10,064,845
Granted Patent B2
US 10,064,845 · App. 15/592,727 · Granted Sep 4, 2018

Compositions and methods of treating muscular dystrophy with thromboxane-A

Inventors: Leo Pavliv (Cary, NC); James West (Nashville, TN); Ines Macias-Perez (Mt. Juliet, TN); Erica Carrier (Nashville, TN)
Assignees: Cumberland Pharmaceuticals, Inc.; Vanderbilt University
A61K31/422
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Quick Facts
Patent No.
US 10,064,845
App. No.
15/592,727
Granted
Sep 4, 2018
Kind
B2
Abstract

The present invention is directed to methods of treating and/or ameliorating muscular dystrophy and/or treating cardiomyopathy in muscular dystrophy patients by administration of a therapeutically effective amount of a thromboxane A 2 receptor antagonist.

Claims (22)

1. A method of treating muscular dystrophy, comprising administering a therapeutically effective amount of a thromboxane A 2 receptor antagonist to a patient suffering from muscular dystrophy.

2. The method of claim 1 , wherein the muscular dystrophy is selected from the group consisting of Duchenne MD (DMD), Becker MD, and Limb-Girdle MD.

3. The method of claim 1 , further comprising administering the thromboxane A 2 antagonist to the patient on a chronic basis.

4. The method of claim 3 , wherein the thromboxane A 2 receptor antagonist is [1S-(1α,2α,3α,4α)]-2-[[3-[4-[(Pentylamino)carbonyl]-2-oxazolyl]-7-oxabicyclo[2.2.1]hept-2-yl]methyl]-benzenepropanoic acid (Ifetroban), and pharmaceutically acceptable salts thereof.

5. The method of claim 3 , wherein the thromboxane A 2 receptor antagonist is [1S-(1α,2α,3α,4α)]-2-[[3-[4-[(Pentylamino)carbonyl]-2-oxazolyl]-7-oxabicyclo[2.2.1]hept-2-yl]methyl]-benzenepropanoic acid, monosodium salt (Ifetroban Sodium).

6. The method of claim 1 , wherein the thromboxane A 2 receptor antagonist is administered orally, intranasally, rectally, vaginally, sublingually, buccally, parenterally, or transdermally.

7. The method of claim 1 , wherein the thromboxane A 2 receptor antagonist is administered parenterally.

8. The method of claim 1 , wherein the thromboxane A 2 receptor antagonist is administered orally.

9. The method of claim 3 , wherein the thromboxane A 2 receptor antagonist is administered prophylactically to prevent cardiomyopathy in the patient.

10. The method of claim 3 , wherein the thromboxane A 2 receptor antagonist is administered prophylactically to prevent gastrointestinal dysfunction in the patient.

11. The method of claim 3 , wherein the therapeutically effective amount is from about 50 mg to about 500 mg, per day.

12. The method of claim 4 , wherein the therapeutically effective amount is from about 150 mg to about 350 mg per day and the ifetroban is administered orally.

13. A method of treating cardiac and/or gastrointestinal dysfunction in a human patient suffering from muscular dystrophy, comprising chronically administering a therapeutically effective amount of a thromboxane A 2 receptor antagonist to the human patient.

14. The method of claim 13 , wherein the therapeutically effective amount is from about 100 mg to about 500 mg, per day.

15. The method of claim 13 , wherein the thromboxane A 2 receptor antagonist is [1S-(1α,2α,3α,4α)]-2-[[3-[4-[(Pentylamino)carbonyl]-2-oxazolyl]-7-oxabicyclo[2.2.1]hept-2-yl]methyl]-benzenepropanoic acid (Ifetroban), and pharmaceutically acceptable salts thereof.

16. The method of claim 15 , wherein the thromboxane A 2 receptor antagonist is [1S-(1α,2α,3α,4α)]-2-[[3-[4-[(Pentylamino)carbonyl]-2-oxazolyl]-7-oxabicyclo[2.2.1]hept-2-yl]methyl]-benzenepropanoic acid, monosodium salt (Ifetroban Sodium).

17. The method of claim 15 , wherein the therapeutically effective amount is from about, 150 mg to about 350 mg per day and the ifetroban is administered orally.

18. The method of claim 13 , wherein the gastrointestinal dysfunction is smooth muscle dysfunction.

19. A method of treating cardiac dysfunction in a human patient suffering from muscular dystrophy, comprising chronically administering a therapeutically effective amount of a thromboxane A 2 receptor antagonist to a human muscular dystrophy patient suffering from cardiac dysfunction.

20. The method of claim 19 , wherein the thromboxane A 2 receptor antagonist is [1S-(1α,2α,3α,4α)]-2-[[3-[4-[(Pentylamino)carbonyl]-2-oxazolyl]-7-oxabicyclo[2.2.1]hept-2-yl]methyl]-benzenepropanoic acid (Ifetroban), and pharmaceutically acceptable salts thereof.

21. The method of claim 19 , wherein the thromboxane A 2 receptor antagonist is [1S-(1α,2α,3α,4α)]-2-[[3-[4-[(Pentylamino)carbonyl]-2-oxazolyl]-7-oxabicyclo[2.2.1]hept-2-yl]methyl]-benzenepropanoic acid, monosodium salt (Ifetroban Sodium).

22. The method of claim 19 , wherein the therapeutically effective amount is from about 50 mg to about 500 mg, per day.

Assignments (2)
CONFIRMATORY LICENSE Recorded Jan 24, 2024
From: VANDERBILT UNIVERSITY
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 066368/0231 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 12, 2017
From: MACIAS-PEREZ, INES; PAVLIV, LEO; CARRIER, ERICA; WEST, JAMES
To: CUMBERLAND PHARMACEUTICALS, INC.; VANDERBILT UNIVERSITY
Reel/Frame 042354/0225 →
Continuity (2)
Provisional Application 62334748 · May 11, 2016
Related Publication 20170340614A1 · Nov 30, 2017