Methods for the Administration of Certain VMAT2 Inhibitors
AssigneeNeurocrine Biosciences, Inc.
InventorsChristopher F. O`Brien, Haig P. Bozigian
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Abstract
Provided are methods of administering a vesicular monoamine transport 2 (VMAT2) inhibitor chosen from valbenazine and (+)-α-3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-ol, or a pharmaceutically acceptable salt and/or isotopic variant thereof, to a patient in need thereof wherein the patient is also being administered digoxin.
Claims29
1-107. (canceled)
A method for treating a patient with tardive dyskinesia, wherein the patient is also being co-administered digoxin, comprising:
- (a) administering to the patient a therapeutically effective amount of a vesicular monoamine transport 2 (VMAT2) inhibitor chosen from (S)-2-amino-3-methyl-butyric acid (2R,3R,11bR)-3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-yl ester, (+)-α-3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-ol, and pharmaceutically acceptable salts and isotopic variants thereof,
- (b) monitoring the digoxin concentration in the patient's blood;
- and
- (c) adjusting the dose of digoxin when the digoxin exposure in the patient's blood is elevated.
A method of treating tardive dyskinesia in a patient in need thereof, wherein the patient is also in need of treatment with digoxin, the method comprising:
- orally administering to the patient a therapeutically effective amount of a vesicular monoamine transport 2 (VMAT2) inhibitor which is (S)-2-amino-3-methyl-butyric acid (2R,3R,11bR)-3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-yl ester ditosylate, and
- administering the digoxin to the patient at a reduced dose to compensate for the expected increase in exposure resulting from co-administration of the digoxin and the VMAT2 inhibitor,
- wherein the reduced dose is relative to what the patient would be administered if the patient is not being administered the VMAT2 inhibitor.
Dependencies are inferred from the claim text.