Compositions for weight management

Abstract

Methods and compositions for regulating food intake in a human subject; for improving a compliance of a human subject to caloric restriction; and for reducing a desire of a human subject to consume fats, utilizing H1-receptor agonists that have a pharmacological half-life that allows an efficient treatment regime thereof are disclosed. The methods and compositions can be efficiently used for treating conditions such as overeating, overweight, obesity, binge eating disorder, night eating syndrome, obsessive eating, compulsive eating and bulimia, as well as conditions associated with metabolic derangement such as dyslipidemia and for preventing or reducing weight gain due to factors such as drug use, cessation of smoking, and the like in a human subject.

1 . A pharmaceutical composition comprising a therapeutically effective amount of an H 1  agonistand a therapeutically effective amount of a drug selected from the group consisting of an antipsychotic, an antidepressant, a mood-stabilizer and an anti-convulsant.  
     
     
         2 . The pharmaceutical composition of  claim 1 , wherein said antipsychotic is selected from the group consisting of a selective serotonin-reuptake inhibitor, a monoamine oxidase inhibitor, a conventional antipsychotic, and an atypical antipsychotic.  
     
     
         3 . The pharmaceutical composition of  claim 2 , wherein said atypical antipsychotic is selected from the group consisting of clozapine, risperidone, quetiapine, sertindole, aripiprazole and ziprasidone.  
     
     
         4 . The pharmaceutical composition of  claim 1 , wherein said anti-depressant is selected from the group consisting of biproprion hydrochloride, mitrazapine, nefazadone and trazadone.  
     
     
         5 . The pharmaceutical composition of  claim 1 , wherein said mood-stabilizer is lithium.  
     
     
         6 . The pharmaceutical composition of  claim 1 , wherein said anti-convulsant is selected from the group consisting of carbamazepine, divalproex, lamotrigine, sodium valproate, valproic acid, and gabapentin.  
     
     
         7 . The pharmaceutical composition of  claim 1 , being packaged in a packaging material and identified in print, in or on said packaging material, for use in the treatment of a medical condition in which treatment with said drug is beneficial while reducing or preventing weight gain associated with said drug treatment.  
     
     
         8 . The pharmaceutical composition of  claim 1 , wherein said H 1  agonist is betahistine or a pharmaceutically acceptable salt thereof.  
     
     
         9 . The pharmaceutical composition of  claim 1 , wherein said H 1  agonist is a betahistine metabolite.  
     
     
         10 . The pharmaceutical composition of  claim 9 , wherein said betahistine metabolite is 2-(2-aminoethyl)-pyridine.  
     
     
         11 . The pharmaceutical composition of  claim 8 , wherein said betahistine salt is selected from the group consisting of betahistine dihydrochloride, betahistine mesilate, and betahistine trimebutine maleate.  
     
     
         12 . The pharmaceutical composition of  claim 8 , wherein said H 1  agonist is a betahistine derivative.  
     
     
         13 . The pharmaceutical composition of  claim 12 , wherein said betahistine derivative is selected from the group of compounds represented by formula I:  
       
         
           
           
               
               
           
         
         wherein each of R 1 -R 12  is independently selected from the group consisting of hydrogen, alkyl, cycloalkyl and aryl.  
       
     
     
         14 . The pharmaceutical composition of  claim 1 , wherein said therapeutically effective amount of said H 1  agonist ranges from about 2 mg per unit dosage to about 96 mg per unit dosage.  
     
     
         15 . The pharmaceutical composition of  claim 1 , being formulated such that said H 1  agonist is in a slow-release form.