IP Library › Granted Patent US 12,357,597
Granted Patent B2
US 12,357,597 · App. 18/151,707 · Granted Jul 15, 2025

Dispersible formulations of N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benazmide and uses thereof

Inventors: Kristin Patterson (Stamford, CT); Jiping Liu (Stamford, CT)
Assignee: SPRINGWORKS THERAPEUTICS, INC.
A61K31/167A61K9/0056A61K9/16A61K9/2013A61K9/2018A61K9/2054A61K9/2072
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Quick Facts
Patent No.
US 12,357,597
App. No.
18/151,707
Granted
Jul 15, 2025
Kind
B2
Abstract

The present disclosure relates to dispersible pharmaceutical compositions comprising N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide, and, optionally, a pharmaceutically acceptable carrier.

Claims (28)

1. A method of treating a human subject who has neurofibromatosis type 1 comprising (i) combining a dispersible pharmaceutical composition of mirdametinib with a potable liquid to form a solution, and (ii) orally administering the solution to the subject.

2. The method of claim 1 , wherein the dispersible pharmaceutical composition disintegrates or dissolves within 10 minutes after being combined with the potable liquid.

3. The method of claim 1 , wherein the subject is a pediatric patient.

4. The method of claim 1 , wherein the subject has a neurofibroma associated with neurofibromatosis type 1.

5. The method of claim 1 , wherein the potable liquid is water.

6. The method of claim 1 , wherein the dispersible pharmaceutical composition is a dispersible tablet.

7. The method of claim 1 , wherein the dispersible pharmaceutical composition is a capsule comprising a dispersible powder of mirdametinib.

8. The method of claim 1 , wherein the dispersible pharmaceutical composition comprises about 0.1 mg to about 20 mg of mirdametinib.

9. The method of claim 1 , wherein the dispersible pharmaceutical composition comprises about 0.5 mg of mirdametinib.

10. The method of claim 1 , wherein the dispersible pharmaceutical composition comprises about 1 mg of mirdametinib.

11. The method of claim 1 , the dispersible pharmaceutical composition comprises from about 0.1 w/w % to about 7 w/w % mirdametinib.

12. The method of claim 1 , wherein the mirdametinib is administered twice daily.

13. The method of claim 1 , wherein the mirdametinib is administered twice daily at a dose of from about 0.1 mg to about 10 mg each.

14. The method of claim 1 , wherein the subject is treated on a 28-day cycle comprising (a) 21 days of oral administration of mirdametinib followed by (b) 7 days without administration of mirdametinib.

15. A method of treating a human subject who has neurofibromatosis type 1 (NF1) comprising orally administering to the subject a liquid prepared by adding a dispersible pharmaceutical composition of mirdametinib to a potable liquid.

16. The method of claim 15 , wherein the dispersible pharmaceutical composition disintegrates or dissolves within 10 minutes after being combined with a potable liquid.

17. The method of claim 15 , wherein the subject is a pediatric patient.

18. The method of claim 15 , wherein the subject has a neurofibroma associated with neurofibromatosis type 1.

19. The method of claim 15 , wherein the potable liquid is water.

20. The method of claim 15 , wherein the dispersible pharmaceutical composition is a dispersible tablet.

21. The method of claim 15 , wherein the dispersible pharmaceutical composition is a capsule comprising a dispersible powder of mirdametinib.

22. The method of claim 15 , wherein the dispersible pharmaceutical composition comprises about 0.1 mg to about 20 mg mirdametinib.

23. The method of claim 15 , wherein the dispersible pharmaceutical composition comprises about 0.5 mg of mirdametinib.

24. The method of claim 15 , wherein the dispersible pharmaceutical composition comprises about 1 mg of mirdametinib.

25. The method of claim 15 , the dispersible pharmaceutical composition comprises from about 0.1 w/w % to about 7 w/w % mirdametinib.

26. The method of claim 15 , wherein the mirdametinib is administered twice daily.

27. The method of claim 15 , wherein the mirdametinib is administered twice daily at a dose of from about 0.1 mg to about 10 mg each dose.

28. The method of claim 15 , wherein the subject is treated on a 28-day cycle comprising (a) 21 days of oral administration of mirdametinib followed by (b) 7 days without administration of mirdametinib.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 7, 2024
From: PATTERSON, KRISTIN; LIU, JIPING
To: SPRINGWORKS THERAPEUTICS, INC.
Reel/Frame 066041/0819 →
Continuity (2)
Division 17177999 · Feb 17, 2021
Related Publication 20230330047A1 · Oct 19, 2023
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