Combination of Brexpiprazole and Nalmefene and Use Thereof for Treating Substance-Related Disorders

Abstract

A medicament comprising (I) brexpiprazole or a pharmaceutically acceptable salt thereof, and (II) nalmefene or a pharmaceutically acceptable salt thereof in combination, wherein brexpiprazole or a pharmaceutically acceptable salt thereof, and nalmefene or a pharmaceutically acceptable salt thereof are contained in a single preparation, or a pharmaceutical composition containing brexpiprazole or a pharmaceutically acceptable salt thereof and a pharmaceutical composition containing nalmefene or a pharmaceutically acceptable salt thereof are formulated for use in combination. The medicament is used for the prophylaxis or treatment of a substance-related disorder, preferably an alcohol-related disorder.

1 . A medicament comprising (I) brexpiprazole or a pharmaceutically acceptable salt thereof, and (II) nalmefene or a pharmaceutically acceptable salt thereof in combination, wherein brexpiprazole or a pharmaceutically acceptable salt thereof, and nalmefene or a pharmaceutically acceptable salt thereof are contained in a single preparation, or a pharmaceutical composition containing brexpiprazole or a pharmaceutically acceptable salt thereof and a pharmaceutical composition containing nalmefene or a pharmaceutically acceptable salt thereof are formulated for use in combination. 
     
     
         2 . The medicament according to  claim 1 , wherein (I) brexpiprazole or a pharmaceutically acceptable salt thereof, and (II) nalmefene or a pharmaceutically acceptable salt thereof are contained in a single preparation. 
     
     
         3 . The medicament according to  claim 1 , wherein a pharmaceutical composition containing brexpiprazole or a pharmaceutically acceptable salt thereof and a pharmaceutical composition containing nalmefene or a pharmaceutically acceptable salt thereof are formulated for use in combination. 
     
     
         4 . The medicament according to any one of  claims 1  to  3 , for use in the prophylaxis or treatment of a substance-related disorder. 
     
     
         5 . The medicament according to  claim 4 , wherein the substance-related disorder is an alcohol-related disorder. 
     
     
         6 . The medicament according to  claim 5 , wherein the alcohol-related disorder is selected from the group consisting of an alcohol use disorder, an alcohol-induced disorder, alcohol abuse, alcohol dependence, alcohol intoxication and an alcohol withdrawal symptom. 
     
     
         7 . The medicament according to  claim 5 , for use in the prophylaxis or treatment of an impulsive symptom in an alcohol-related disorder. 
     
     
         8 . The medicament according to  claim 7 , wherein the alcohol-related disorder is selected from the group consisting of an alcohol use disorder, an alcohol-induced disorder, alcohol abuse, alcohol dependence, alcohol intoxication and an alcohol withdrawal symptom. 
     
     
         9 . The medicament according to  claim 8 , wherein the alcohol-related disorder is alcohol dependence. 
     
     
         10 . A medicament comprising brexpiprazole or a pharmaceutically acceptable salt thereof, for a combined use with nalmefene or a pharmaceutically acceptable salt thereof. 
     
     
         11 . A medicament comprising nalmefene or a pharmaceutically acceptable salt thereof, for a combined use with brexpiprazole or a pharmaceutically acceptable salt thereof. 
     
     
         12 . Use of (I) brexpiprazole or a pharmaceutically acceptable salt thereof in combination with (II) nalmefene or a pharmaceutically acceptable salt thereof for the production of a medicament for the prophylaxis or treatment of a substance-related disorder. 
     
     
         13 . A method for preventing or treating a substance-related disorder, comprising administering (I) brexpiprazole or a pharmaceutically acceptable salt thereof, and (II) nalmefene or a pharmaceutically acceptable salt thereof to a subject in need thereof, wherein brexpiprazole or a pharmaceutically acceptable salt thereof, and nalmefene or a pharmaceutically acceptable salt thereof are administered as a single preparation or separate preparations simultaneously or separately in a staggered manner. 
     
     
         14 . A pharmaceutical composition comprising (I) brexpiprazole or a pharmaceutically acceptable salt thereof, (II) nalmefene or a pharmaceutically acceptable salt thereof, and (III) a pharmacologically acceptable carrier. 
     
     
         15 . A method for producing a pharmaceutical composition, comprising mixing (I) brexpiprazole or a pharmaceutically acceptable salt thereof and (II) nalmefene or a pharmaceutically acceptable salt thereof with a pharmacologically acceptable carrier. 
     
     
         16 . A kit comprising (I) a medicament containing brexpiprazole or a pharmaceutically acceptable salt thereof, and (II) a medicament containing nalmefene or a pharmaceutically acceptable salt thereof. 
     
     
         17 . The medicament according to any one of  claims 1  to  3 , for treating a patient for whom an existing therapeutic drug for alcohol-related disorder provides only an insufficient effect. 
     
     
         18 . The medicament according to  claim 17 , wherein the existing therapeutic drug for alcohol-related disorder is selected from the group consisting of cyanamide, disulfiram, acamprosate, nalmefene and naltrexone. 
     
     
         19 . A medicament for use in the treatment of an alcohol-related disorder, comprising brexpiprazole or a pharmaceutically acceptable salt thereof as an active ingredient, which is used for a patient receiving a treatment with a preparation of nalmefene or a pharmaceutically acceptable salt thereof. 
     
     
         20 . A medicament for use in the treatment of an alcohol-related disorder, comprising nalmefene or a pharmaceutically acceptable salt thereof as an active ingredient, which is used for a patient receiving a treatment with a preparation of brexpiprazole or a pharmaceutically acceptable salt thereof.