2-(Pyridin-2-yl)-1, 7-Diaza-Spiro [4.4] Nonane-6-One Compound as Voltage-Gated Sodium Channel Modulator

Abstract

The invention relates to spiro derivatives, to the use of said derivatives in treating diseases and conditions mediated by modulation of voltage-gated sodium channels, to compositions containing said derivatives and processes for their preparation.

What is claimed is: 
     
         1 .- 11 . (canceled) 
     
     
         12 . A method for treating a disease or condition mediated by modulation of voltage-gated sodium channels, comprising administering to the patient an effective amount of a compound of formula (I) which is 7-methyl-2-[4-[3-(trifluoromethoxy)phenyl]-2-pyridyl]-1,7-diazaspiro[4.4]nonan-6-one: 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof. 
       
     
     
         13 . The method of  claim 12 , wherein the compound of formula (I) is a compound of any one of formulae (Ia)-(Id): 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof. 
       
     
     
         14 . The method of  claim 13 , wherein the compound of formula (I) is a compound of formula (Ia): 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof. 
       
     
     
         15 . The method of  claim 12 , wherein the compound of formula (I) or pharmaceutically acceptable salt thereof is (2R,5 S)-7-Methyl-2-[4-[3-(trifluoromethoxy)phenyl]-2-pyridyl]-1,7-diazaspiro[4.4]nonan-6-one hydrochloride (E1). 
     
     
         16 . The method of  claim 12 , wherein the compound of formula (I) or pharmaceutically acceptable salt thereof is (2R,5S)-7-Methyl-2-[4-[3-(trifluoromethoxy)phenyl]-2-pyridyl]-1,7-diazaspiro[4.4]nonan-6-one hemisulfate (E2). 
     
     
         17 . The method of  claim 12 , wherein the compound of formula (I) or pharmaceutically acceptable salt thereof is (2S,5S)-7-Methyl-2-[4-[3-(trifluoromethoxy)phenyl]-2-pyridyl]-1,7-diazaspiro[4.4]nonan-6-one hydrochloride (E3). 
     
     
         18 . A method for treating a disease or condition mediated by modulation of voltage-gated sodium channels, comprising administering to the patient an effective amount of a pharmaceutical composition comprising a compound of formula (I) 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof with one or more pharmaceutically acceptable carrier(s), diluents(s) and/or excipient(s). 
       
     
     
         19 . A process for preparing a compound of formula (I) 
       
         
           
           
               
               
           
         
         which comprises: 
         (a) reacting a compound of formula (II): 
       
       
         
           
           
               
               
           
         
         or a protected derivative thereof, wherein L 1  represents a suitable leaving group such as a halogen atom (e.g. bromine) or an —O—SO 2 CF 3  group, with a compound of formula (III): 
       
       
         
           
           
               
               
           
         
         wherein X represents boronic acid; 
         (b) reducing a compound of formula (IV): 
       
       
         
           
           
               
               
           
         
         or a protected derivative thereof; 
         (c) deprotecting a protected derivative of a compound of formula (I); and 
         (d) optionally forming a pharmaceutically acceptable salt of a compound of formula (I).