Hydroxyrisperidone compositions and methods

Abstract

Methods and compositions utilizing compounds represented by Formula III, or a pharmaceutically acceptable salt thereof, for the treatment and prevention of psychoses in humans are disclosed. Compounds of the present invention exhibit fewer side effects than risperidone, a lessened liability toward drug-drug interactions than risperidone and a more predictable dosing regimen than risperidone. Compounds of the invention are also useful for the treatment and prevention of emesis and withdrawal syndromes.

1 . A method of treating psychoses while avoiding the concomitant liability of side effects associated with risperidone which comprises administering to a human an amount of a compound represented by Formula III,  
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof, sufficient to treat psychoses but insufficient to cause said side effects.  
     
     
         2 . A method of providing a predictable dosing regimen in the treatment of psychoses which comprises administering to a human a therapeutically effective amount of a compound represented by Formula III,  
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof.  
     
     
         3 . A method of reducing potential for drug-drug interactions in the treatment of psychoses which comprises administering to a human a therapeutically effective amount of a compound represented by Formula III,  
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof.  
     
     
         4 . A method of suppressing emesis which comprises administering to a human a therapeutically effective amount of a compound represented by Formula III,  
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof.  
     
     
         5 . A method of treating withdrawal from alcohol, nicotine or narcotic drugs which comprises administering to a human a therapeutically effective amount of a compound represented by Formula III,  
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof.  
     
     
         6 . (cancelled)  
     
     
         7 . The method of  claim 1  wherein the compound is administered orally.  
     
     
         8 . The method of  claim 7  wherein the amount of the compound, or a pharmaceutically acceptable salt thereof administered is from about 1 mg to about 20 mg per day.  
     
     
         9 - 12 . (cancelled)  
     
     
         13 . The method of  claim 2  wherein the compound is administered orally.  
     
     
         14 . The method of  claim 13  wherein the amount of the compound, or a pharmaceutically acceptable salt thereof administered is from about 1 mg to about 20 mg per day.  
     
     
         15 . The method of  claim 3  wherein the compound is administered orally.  
     
     
         16 . The method of  claim 15  wherein the amount of the compound, or a pharmaceutically acceptable salt thereof administered is from about 1 mg to about 20 mg per day.  
     
     
         17 . The method of  claim 4  wherein the compound is administered orally.  
     
     
         18 . The method of  claim 17  wherein the amount of the compound, or a pharmaceutically acceptable salt thereof administered is from about 1 mg to about 20 mg per day.  
     
     
         19 . The method of  claim 5  wherein the compound is administered orally.  
     
     
         20 . The method of  claim 19  wherein the amount of the compound, or a pharmaceutically acceptable salt thereof administered is from about 1 mg to about 20 mg per day.