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Last Updated: April 2, 2026

Claims for Patent: 12,357,597

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Summary for Patent: 12,357,597

Title:	Dispersible formulations of N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benazmide and uses thereof
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.
Inventor(s):	Kristin Patterson, Jiping Liu
Assignee:	SpringWorks Therapeutics Inc
Application Number:	US18/151,707
Patent Claims:	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.

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