Claims for Patent: 11,060,128

Summary for Patent: 11,060,128

Title:	Methods of administering 3,4-diaminopyridine
Abstract:	Provided herein are methods of determining NAT acetylation status of a subject with a 3,4-DAP-sensitive disease, methods of selecting a dose of 3,4-DAP or a pharmaceutically acceptable salt thereof adjusted to a subject's acetylation status, methods of administering 3,4-diaminopyridine or a pharmaceutically acceptable salt thereof to a patient in need thereof, and methods of treating 3,4-DAP sensitive diseases.
Inventor(s):	Garovoy; Marvin R. (Sausalito, CA), Haroldsen; Peter E. (Pacifica, CA), Musson; Donald G. (Larkspur, CA)
Assignee:	SERB SA (Brussels, BE)
Application Number:	17/009,250
Patent Claims:	1. A method of treating a human patient diagnosed with Lambert-Eaton myasthenic syndrome (LEMS) in need of treatment thereof comprising administering a total daily dose of about 7.5 mg to about 40 mg of 3,4-diaminopyridine (3,4-DAP), or an equivalent amount of a pharmaceutically acceptable salt thereof, to a human patient who is a N-acetyl transferase 2 (NAT2) slow acetylator, wherein the total daily dose is optionally provided as a series of divided doses. 2. The method of claim 1, wherein the about 7.5 mg to about 40 mg of 3,4-DAP is provided via an equivalent amount of 3,4-DAP phosphate salt. 3. The method of claim 1, wherein the total daily dose is provided via up to 5 divided doses per day. 4. The method of claim 3, wherein the divided dose is about 2.5 mg of 3,4-DAP, or the equivalent amount of a pharmaceutically acceptable salt thereof. 5. The method of claim 3, wherein the divided dose is about 5 mg of 3,4-DAP, or the equivalent amount of a pharmaceutically acceptable salt thereof. 6. The method of claim 3, wherein the divided dose is about 10 mg of 3,4-DAP, or the equivalent amount of a pharmaceutically acceptable salt thereof. 7. The method of claim 3, wherein the divided dose is about 15 mg of 3,4-DAP, or the equivalent amount of a pharmaceutically acceptable salt thereof. 8. The method of claim 3, wherein the divided dose is about 20 mg of 3,4-DAP, or the equivalent amount of a pharmaceutically acceptable salt thereof. 9. The method of claim 3, wherein the divided dose is provided as one or more scored tablets or portions thereof. 10. The method of claim 9, wherein the scored tablet comprises about 10 mg of 3,4-DAP, or the equivalent amount of a pharmaceutically acceptable salt thereof. 11. The method of claim 3, wherein the divided dose is provided as an aqueous suspension. 12. The method of claim 1, wherein the total daily dose is about 15 mg to about 30 mg of 3,4-DAP, or the equivalent amount of a pharmaceutically acceptable salt thereof. 13. The method of claim 12, wherein the total daily dose is provided via 3 to 4 divided doses per day. 14. The method of claim 12, wherein the total daily dose is provided via 2 to 3 divided doses per day. 15. The method of claim 12, wherein the total daily dose is about 15 mg of 3,4-DAP, or the equivalent amount of a pharmaceutically acceptable salt thereof. 16. The method of claim 12, wherein total daily dose is about 30 mg of 3,4-DAP, or the equivalent amount of a pharmaceutically acceptable salt thereof. 17. The method of claim 1, wherein the total daily dose is about 7.5 mg to about 15 mg of 3,4-DAP, or the equivalent amount of a pharmaceutically acceptable salt thereof. 18. The method of claim 17, wherein the total daily dose is provided via 2 to 3 divided doses per day. 19. The method of claim 17, wherein the total daily dose is about 7.5 mg of 3,4-DAP, or the equivalent amount of a pharmaceutically acceptable salt thereof. 20. The method of claim 1, wherein the patient suffers from renal impairment. 21. A method of treating a human patient diagnosed with LEMS in need of treatment thereof comprising administering a total daily dose of about 7.5 mg to about 15 mg of 3,4-DAP, or an equivalent amount of a pharmaceutically acceptable salt thereof, as a series of divided doses to a human patient who is a NAT2 slow acetylator. 22. The method of claim 21, wherein the about 7.5 mg to about 15 mg of 3,4-DAP is provided via the equivalent amount of 3,4-DAP phosphate salt. 23. The method of claim 21, wherein the total daily dose is provided via 2 to 3 divided doses per day. 24. A method of treating a human patient diagnosed with LEMS in need of treatment thereof comprising administering a total daily dose of about 15 mg to about 30 mg of 3,4-DAP, or an equivalent amount of a pharmaceutically acceptable salt thereof, as a series of divided doses to a human patient who is a NAT2 slow acetylator. 25. The method of claim 24, wherein the about 15 mg to about 30 mg of 3,4-DAP is provided via the equivalent amount of 3,4-DAP phosphate salt. 26. The method of claim 24, wherein total daily dose is provided via 2 to 3 divided doses per day. 27. A method of treating a human patient diagnosed with LEMS in need of treatment thereof comprising administering a total daily dose of 3,4-DAP phosphate salt, which is equivalent to a total daily dose of about 7.5 mg to about 30 mg of 3,4-DAP, as a series of divided doses to a human patient who is a NAT2 slow acetylator. 28. The method of claim 27, wherein total daily dose is provided via 2 to 3 divided doses per day.