Claims for Patent: 11,274,332

Summary for Patent: 11,274,332

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:	17/503,148
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 diagnosed with LEMS having two N-acetyl transferase 2 (NAT2) slow alleles, wherein the total daily dose is optionally provided as a series of divided doses. 2. The method of claim 1, wherein the two NAT2 slow alleles each comprise one or more of a 282T, 341C, 191A, 481T, 590A, or 857A mutation. 3. The method of claim 2, wherein the two NAT2 slow alleles each comprise a 282T, a 341C, or a 282T and a 341C mutation. 4. 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. 5. The method of claim 1, wherein the total daily dose is provided via up to 5 divided doses per day. 6. The method of claim 5, wherein the divided dose is provided as one or more scored tablets or portions thereof. 7. The method of claim 6, wherein the scored tablet comprises about 10 mg of 3,4-DAP, or the equivalent amount of a pharmaceutically acceptable salt thereof. 8. The method of claim 5, wherein the divided dose is provided as an aqueous suspension. 9. 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. 10. The method of claim 9, wherein the total daily dose is provided via 3 to 4 divided doses per day. 11. The method of claim 9, wherein the total daily dose is provided via 2 to 3 divided doses per day. 12. The method of claim 9, wherein the total daily dose is about 15 mg of 3,4-DAP, or the equivalent amount of a pharmaceutically acceptable salt thereof. 13. The method of claim 9, wherein total daily dose is about 30 mg of 3,4-DAP, or the equivalent amount of a pharmaceutically acceptable salt thereof. 14. 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. 15. The method of claim 14, wherein the total daily dose is provided via 2 to 3 divided doses per day. 16. The method of claim 14, wherein the total daily dose is about 7.5 mg of 3,4-DAP, or the equivalent amount of a pharmaceutically acceptable salt thereof. 17. The method of claim 1, wherein the patient suffers from renal impairment. 18. 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 diagnosed with LEMS having two NAT2 slow alleles. 19. The method of claim 18, wherein the two NAT2 slow alleles each comprise one or more of a 282T, 341C, 191A, 481T, 590A, or 857A mutation. 20. The method of claim 19, wherein the two NAT2 slow alleles each comprise a 282T, a 341C, or a 282T and a 341C mutation. 21. 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 diagnosed with LEMS having two NAT2 slow alleles. 22. The method of claim 21, wherein the two NAT2 slow alleles each comprise one or more of a 282T, 341C, 191A, 481T, 590A, or 857A mutation. 23. The method of claim 22, wherein the two NAT2 slow alleles each comprise a 282T, a 341C, or a 282T and a 341C mutation. 24. 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 diagnosed with LEMS having two NAT2 slow alleles. 25. The method of claim 24, wherein the two NAT2 slow alleles each comprise one or more of a 282T, 341C, 191A, 481T, 590A, or 857A mutation. 26. The method of claim 25, wherein the two NAT2 slow alleles each comprise a 282T, a 341C, or a 282T and a 341C mutation.