US2020206215A1PendingUtilityA1

Pharmaceutical Compositions Comprising an Antipsychotic Drug and a VMAT2 Inhibitor and Uses Thereof

Assignee: NEUROCRINE BIOSCIENCES INCPriority: Feb 7, 2014Filed: Mar 13, 2020Published: Jul 2, 2020
Est. expiryFeb 7, 2034(~7.5 yrs left)· nominal 20-yr term from priority
A61P 25/18A61K 45/06A61K 31/519A61K 31/4745A61K 31/00A61K 31/5415A61K 2300/00A61K 31/551A61P 43/00A61P 25/24A61K 31/5513A61K 31/473
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Claims

Abstract

New methods of treating schizophrenia and schizoaffective disorder by administration of pharmaceutical compositions comprising an antipsychotic compound and a VMAT2 inhibitor to a subject in need thereof are provided.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method for treating a movement disorder in a subject in need thereof wherein the subject is also being administered an antipsychotic drug, comprising:
 administering to the subject a therapeutically effective amount of (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 or a pharmaceutically acceptable salt thereof.   
     
     
         2 . The method of  claim 1 , wherein the movement disorder is tardive dyskinesia. 
     
     
         3 . The method of  claim 1 , wherein the movement disorder is chorea associated with Huntington's disease. 
     
     
         4 . The method of  claim 1 , wherein the antipsychotic drug is a typical antipsychotic drug. 
     
     
         5 . The method of  claim 1 , wherein the antipsychotic drug is an atypical antipsychotic drug. 
     
     
         6 . The method of  claim 1 , wherein the subject is being administered the antipsychotic drug for the treatment of schizophrenia. 
     
     
         7 . The method of  claim 1 , wherein the subject is being administered the antipsychotic drug for the treatment of schizoaffective disorder. 
     
     
         8 . The method of  claim 1 , wherein the subject is administered (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 or a pharmaceutically acceptable salt thereof in an amount of 10 to 100 mg per day. 
     
     
         9 . The method of  claim 1 , wherein the (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 or a pharmaceutically acceptable salt thereof is administered orally. 
     
     
         10 . The method of  claim 1 , wherein the (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 or a pharmaceutically acceptable salt thereof is administered once daily. 
     
     
         11 . The method of  claim 1 , wherein the (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 or a pharmaceutically acceptable salt thereof is administered independently of the antipsychotic drug. 
     
     
         12 . A method for treating a movement disorder associated with administration of an antipsychotic drug to a subject in need thereof, comprising:
 administering the antipsychotic drug and a therapeutically effective amount of (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 or a pharmaceutically acceptable salt thereof to the subject.   
     
     
         13 . The method of  claim 12 , wherein the movement disorder is tardive dyskinesia. 
     
     
         14 . The method of  claim 12 , wherein the movement disorder is chorea associated with Huntington's disease. 
     
     
         15 . The method of  claim 12 , wherein the antipsychotic drug is a typical antipsychotic drug. 
     
     
         16 . The method of  claim 12 , wherein the antipsychotic drug is an atypical antipsychotic drug. 
     
     
         17 . The method of  claim 12 , wherein the subject is being administered the antipsychotic drug for the treatment of schizophrenia. 
     
     
         18 . The method of  claim 12 , wherein the subject is being administered the antipsychotic drug for the treatment of schizoaffective disorder. 
     
     
         19 . The method of  claim 12 , wherein the subject is administered (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 or a pharmaceutically acceptable salt thereof in an amount of 10 to 100 mg per day. 
     
     
         20 . The method of  claim 12 , wherein the (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 or a pharmaceutically acceptable salt thereof is administered orally. 
     
     
         21 . The method of  claim 12 , wherein the (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 or a pharmaceutically acceptable salt thereof is administered once daily. 
     
     
         22 . The method of  claim 12 , wherein the (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 or a pharmaceutically acceptable salt thereof is administered independently of the antipsychotic drug.

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