Claims for Patent: 11,274,331

Summary for Patent: 11,274,331

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:	17/503,092
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 30 mg to about 240 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) fast 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 fast alleles are wild-type alleles. 3. The method of claim 1, wherein the about 30 mg to about 240 mg of 3,4-DAP is provided via an equivalent amount of 3,4-DAP phosphate salt. 4. The method of claim 1, wherein the total daily dose is about 30 mg to about 100 mg of 3,4-DAP, or an equivalent amount of a pharmaceutically acceptable salt thereof. 5. The method of claim 4, wherein the total daily dose is about 30 mg to about 80 mg of 3,4-DAP, or an equivalent amount of a pharmaceutically acceptable salt thereof. 6. The method of claim 5, wherein the total daily dose is about 30 mg to about 50 mg of 3,4-DAP, or an equivalent amount of a pharmaceutically acceptable salt thereof. 7. The method of claim 4, wherein the total daily dose is provided via up to 5 divided doses per day. 8. The method of claim 7, wherein the total daily dose is provided via 3 to 4 divided doses per day. 9. The method of claim 7, wherein the total daily dose is provided via 2 to 3 divided doses per day. 10. The method of claim 4, wherein the total daily dose is provided as a series of divided doses, and each divided dose is about 10 mg, about 15 mg, about 20 mg, about 25 mg, or about 30 mg of 3,4-DAP, or the equivalent amount of a pharmaceutically acceptable salt thereof. 11. The method of claim 4, wherein the total daily dose is provided as a series of divided doses, and each divided dose is provided as one or more scored tablets or portions thereof. 12. The method of claim 11, wherein the scored tablet comprises about 10 mg of 3,4-DAP, or the equivalent amount of a pharmaceutically acceptable salt thereof. 13. The method of claim 4, wherein the total daily dose is provided as a series of divided doses, and each divided dose is provided as an aqueous suspension. 14. The method of claim 4, wherein the total daily dose is about 30 mg of 3,4-DAP, or the equivalent amount of a pharmaceutically acceptable salt thereof. 15. The method of claim 4, wherein the total daily dose is about 50 mg of 3,4-DAP, or the equivalent amount of a pharmaceutically acceptable salt thereof. 16. The method of claim 4, wherein the total daily dose is about 60 mg of 3,4-DAP, or the equivalent amount of a pharmaceutically acceptable salt thereof. 17. The method of claim 4, wherein the total daily dose is about 80 mg of 3,4-DAP, or the equivalent amount of a pharmaceutically acceptable salt thereof. 18. The method of claim 4, wherein the total daily dose is about 100 mg of 3,4-DAP, or the equivalent amount of a pharmaceutically acceptable salt thereof. 19. A method of treating a human patient diagnosed with LEMS in need of treatment thereof comprising administering a total daily dose of about 30 mg to about 100 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 fast alleles. 20. The method of claim 19, wherein the two NAT2 fast alleles are wild-type alleles. 21. The method of claim 19, wherein the total daily dose is provided via up to 5 divided doses per day. 22. The method of claim 21, wherein the total daily dose is about 30 mg of 3,4-DAP, or the equivalent amount of a pharmaceutically acceptable salt thereof. 23. The method of claim 21, wherein the total daily dose is about 50 mg of 3,4-DAP, or the equivalent amount of a pharmaceutically acceptable salt thereof. 24. The method of claim 21, wherein the total daily dose is about 60 mg of 3,4-DAP, or the equivalent amount of a pharmaceutically acceptable salt thereof. 25. The method of claim 21, wherein the total daily dose is about 80 mg of 3,4-DAP, or the equivalent amount of a pharmaceutically acceptable salt thereof. 26. The method of claim 21, wherein the total daily dose is about 100 mg of 3,4-DAP, or the equivalent amount of a pharmaceutically acceptable salt thereof. 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 30 mg to about 100 mg of 3,4-DAP, as a series of divided doses to a human patient diagnosed with LEMS having two NAT2 fast alleles. 28. The method of claim 27, wherein the two NAT2 fast alleles are wild-type alleles.