Claims for Patent: 10,793,893

Summary for Patent: 10,793,893

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. (San Anselmo, CA), Haroldsen; Peter E. (Pacifica, CA), Musson; Donald G. (Greenbrae, CA)
Assignee:	SERB SA (Brussels, BE)
Application Number:	14/128,672
Patent Claims:	1. A method of treating a human patient diagnosed with a 3,4-diaminopyridine (3,4-DAP) sensitive disease in need of treatment thereof comprising administering a dose of about 2.5 mg to about 30 mg of 3,4-DAP or a pharmaceutically acceptable salt thereof to a human patient who is a slow acetylator having an N-acetyl transferase 2 (NAT2) gene comprising: a C282T mutation on both alleles of the NAT2 gene; a T341C mutation on both alleles of the NAT2 gene; or a C282T mutation on one allele of the NAT2 gene and a T341C mutation on the other allele of the NAT2 gene. 2. The method of claim 1, wherein the 3,4-DAP-sensitive disease is Lambert-Eaton myasthenic syndrome (LEMS), myasthenia gravis, or congenital myasthenia. 3. The method of claim 1, wherein the patient has a maximum plasma concentration of about 90 ng/mL of 3,4-DAP following administration of the dose. 4. The method of claim 1, wherein the patient has a maximum plasma concentration of about 15 ng/mL to about 40 ng/mL of 3,4-DAP following administration of the dose. 5. The method of claim 1, wherein the pharmaceutically acceptable salt is a phosphate salt. 6. The method of claim 1, wherein the dose administered is a total daily dose. 7. The method of claim 6, wherein the total daily dose is orally administered in one, two, three, four, or five single doses per day. 8. The method of claim 7, wherein the single dose is provided as one or more scored tablets or portions thereof. 9. The method of claim 8, wherein the scored tablet comprises about 10 mg of 3,4-DAP or a pharmaceutically acceptable salt thereof. 10. The method of claim 7, wherein each single dose comprises about 5 mg to about 30 mg of 3,4-DAP or a pharmaceutically acceptable salt thereof. 11. The method of claim 6, wherein the total daily dose is about 15 mg to about 30 mg of 3,4-DAP or a pharmaceutically acceptable salt thereof. 12. The method of claim 11, wherein the total daily dose is orally administered in 3 or 4 single doses per day. 13. The method of claim 11, wherein the total daily dose is about 15 mg of 3,4-DAP or a pharmaceutically acceptable salt thereof orally administered in 3 single doses per day. 14. The method of claim 11, wherein the total daily dose is about 30 mg of 3,4-DAP or a pharmaceutically acceptable salt thereof orally administered in 3 single doses per day. 15. The method of claim 6, wherein the total daily dose is about 7.5 mg to about 15 mg of 3,4-DAP or a pharmaceutically acceptable salt thereof.