1-aminocyclohexane derivatives for the treatment of cochlear tinnitus

Abstract

The present invention relates to the treatment of an individual afflicted with tinnitus associated with hearing loss comprising administering to the individual an effective amount of a 1-amino-alkylcyclohexane derivative.

1 . A method of treating or preventing tinnitus associated with hearing loss in a subject in need thereof, comprising administering an effective amount of a 1-amino-alkylcyclohexane derivative. 
     
     
         2 . The method of  claim 1 , wherein the tinnitus is associated with mild hearing loss. 
     
     
         3 . The method of  claim 1 , wherein the 1-amino-alkylcyclohexane derivative is neramexane or a pharmaceutically acceptable salt thereof. 
     
     
         4 . The method of  claim 3 , wherein the 1-amino-alkylcyclohexane derivative is neramexane mesylate. 
     
     
         5 . The method of  claim 4 , wherein neramexane mesylate is administered in a range from about 5 mg to about 150 mg/day. 
     
     
         6 . The method of  claim 4 , wherein neramexane mesylate is administered in a range from about 5 mg to about 100 mg/day. 
     
     
         7 . The method of  claim 4 , wherein neramexane mesylate is administered in a range from about 5 mg to about 75 mg/day. 
     
     
         8 . The method of  claim 4 , wherein neramexane mesylate is administered at about 50 mg/day. 
     
     
         9 . The method of  claim 4 , wherein neramexane mesylate is administered at about 75 mg/day. 
     
     
         10 . The method of  claim 3 , wherein neramexane or a pharmaceutically acceptable salt thereof is administered once a day, twice a day (b.i.d.), or three times a day. 
     
     
         11 . The method of  claim 10 , wherein neramexane or a pharmaceutically acceptable salt thereof is administered twice a day. 
     
     
         12 . The method of  claim 3 , wherein neramexane or a pharmaceutically acceptable salt thereof is administered in an immediate release formulation. 
     
     
         13 . The method of  claim 3 , wherein neramexane or a pharmaceutically acceptable salt thereof is administered in a modified release formulation. 
     
     
         14 . The method of  claim 1 , wherein an additional pharmaceutical agent which has been shown to be effective in treating or preventing tinnitus and, optionally, at least one pharmaceutically acceptable carrier or excipient is administered. 
     
     
         15 . The method of  claim 1 , wherein an additional pharmaceutical agent selected from antidepressants or anti-anxiety drugs, dopamine antagonists, Alpha2Delta ligands, and NK1 antagonists and, optionally, at least one pharmaceutically acceptable carrier or excipient is administered. 
     
     
         16 . The method of  claim 15 , wherein the antidepressant or the anti-anxiety drug is a selective serotonin reuptake inhibitor (SSRI), a serotonin-norepinephrine reuptake inhibitor (SNRI), a noradrenergic and specific serotonergic antidepressant (NASSA), a norepinephrine (noradrenaline) reuptake inhibitor (NRI), a norepinephrine-dopamine reuptake inhibitor, or a serotonin 1A agonist. 
     
     
         17 . The method of  claim 15 , wherein the 1-amino-alkylcyclohexane derivative is neramexane or a pharmaceutically acceptable salt thereof. 
     
     
         18 . The method of  claim 17 , wherein neramexane, or a pharmaceutically acceptable salt thereof, and the additional pharmaceutical agent are administered conjointly. 
     
     
         19 . The method of  claim 18 , wherein neramexane, or a pharmaceutically acceptable salt thereof and the additional pharmaceutical agent are administered in a single formulation.