IP Library Granted Patent US 10,456,380
Granted Patent B2
US 10,456,380 · App. 16/240,368 · Granted Oct 29, 2019

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 PHARMACEUTICLS INC.; VANDERBILT UNIVERSITY
A61K31/422
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Quick Facts
Patent No.
US 10,456,380
App. No.
16/240,368
Granted
Oct 29, 2019
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 (20)

1. A method of treating Duchenne muscular dystrophy in a patient in need of treatment thereof, comprising administering a therapeutically effective amount of a thromboxane A 2 receptor antagonist to the patient, 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), or a pharmaceutically acceptable salt thereof.

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

3. The method of claim 1 , 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).

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

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

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

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

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

9. The method of claim 1 , wherein the therapeutically effective amount is from 50 mg to 500 mg per day.

10. The method of claim 1 , wherein the therapeutically effective amount is from 150 mg to 350 mg per day and the ifetroban or pharmaceutically acceptable salt thereof is administered orally.

11. A method of treating cardiac dysfunction in a human patient suffering from muscular dystrophy, comprising administering a therapeutically effective amount of a thromboxane A 2 receptor antagonist to the human patient, 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), or a pharmaceutically acceptable salt thereof.

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

13. The method of claim 11 , 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).

14. The method of claim 11 , wherein the therapeutically effective amount is from 150 mg to 350 mg per day and the ifetroban or pharmaceutically acceptable salt thereof is administered orally.

15. The method of claim 1 , wherein the thromboxane A 2 receptor antagonist is administered orally once per day.

16. The method of claim 15 , wherein the therapeutically effective amount is 50 mg.

17. The method of claim 15 , wherein the therapeutically effective amount is 100 mg.

18. The method of claim 15 , wherein the therapeutically effective amount is 150 mg.

19. The method of claim 15 , wherein the therapeutically effective amount is 300 mg.

20. The method of claim 11 , wherein the thromboxane A 2 receptor antagonist is administered orally once 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 066368/0250 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 4, 2019
From: PAVLIV, LEO; MACIAS-PEREZ, INES; WEST, JAMES; CARRIER, ERICA
To: CUMBERLAND PHARMACEUTICALS INC.; VANDERBILT UNIVERSITY
Reel/Frame 047907/0571 →
Continuity (4)
Continuation 16050798 · Jul 31, 2018
Continuation 15592727 · May 11, 2017
Provisional Application 62334748 · May 11, 2016
Related Publication 20190142807A1 · May 16, 2019