Nalmefene for reduction of alcohol consumption in specific target populations

Abstract

The present invention relates to nalmefene for use in the reduction of alcohol consumption in a patient with alcohol dependence who has a high drinking risk level. The present invention also relates to nalmefene for use in the reduction of alcohol consumption in a patient with alcohol dependence who maintains a high DRL after an observation period following initial assessment.

1 . A method of reducing alcohol consumption in a patient wherein said method comprises the following steps:
 a identifying a patient i) who has a high DRL, and ii) who maintains a high DRL after an observation period following initial assessment, and   b) administering a therapeutically effective amount of nalmefene to the patient identified in step a), wherein said nalmefene is to be administered as-needed about 1-2 hours prior to the anticipated time of drinking.   
     
     
         2 . The method according to  claim 1 , wherein said observation period following initial assessment is about 1-2 weeks. 
     
     
         3 . The method according to  claim 1 , wherein the patient identified in step a) has a DRL corresponding to consumption ≧60 g/day of pure alcohol for men and ≧40 g/day for women. 
     
     
         4 . The method according to  claim 1 , wherein said high URL in identified in step a) i) has been assessed by calculating mean daily alcohol consumption in g/day over a period preceding assessment, wherein said period is 1 week or longer. 
     
     
         5 . The method according to  claim 1 , wherein said maintained DRL in step a) ii) is assessed by calculating mean daily alcohol consumption in g/day over said observation period. 
     
     
         6 . The method according to  claim 1 , wherein said patient is subject to counseling focused on enhanced treatment adherence and reduced alcohol consumption. 
     
     
         7 . The method according to  claim 6 , wherein said counseling is performed according to the BRENDA model. 
     
     
         8 . The method according to  claim 1 , wherein said nalmefene is to be used for a treatment period of 6-12 months. 
     
     
         9 . The method according to  claim 1 , wherein said patient is 12 years or older. 
     
     
         10 . The method according to  claim 1 - 9 , wherein the amount of nalmefene is 10-20 mg. 
     
     
         11 . The method according to any of  claim 1 , wherein said nalmefene is administered in the form of a pharmaceutically acceptable acid addition salt. 
     
     
         12 . The method according to  claim 11 , wherein said nalmefene is administered in the form of the hydrochloride dihydrate. 
     
     
         13 . The method according to  claim 1 , wherein said nalmefene is administered in an oral dose for that is tablets or capsules. 
     
     
         14 . The method according to  claim 1 , wherein said nalmefene is administered in combination with a further active ingredient 
     
     
         15 . The method according to  claim 1 , wherein said patient has an alcohol use disorder. 
     
     
         16 . The method according to  claim 1 , wherein said patient has alcohol dependence.