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 at least medium DRL after an observation period following initial assessment.

1 - 27 . (canceled) 
     
     
         28 . A method for reducing alcohol consumption in a patient with alcohol dependence who has a high DRL, which method comprises administering a therapeutically effective amount of nalmefene to said patient. 
     
     
         29 . The method according to  claim 28 , wherein said patient has a DRL corresponding to consumption ≧60 g/day of pure alcohol for men and >40 g/day for women. 
     
     
         30 . The method according to  claim 29 , wherein said maintained high DRL is assessed by calculating mean daily alcohol consumption in g/day over said observation period. 
     
     
         31 . The method according to  claim 28 , wherein nalmefene is administered in a dose of 10-20 mg. 
     
     
         32 . The method according to  claim 28 , where in nalmefene is administered for a treatment period of 6 -12 months. 
     
     
         33 . The method according to  claim 28 , wherein said nalmefene is administered to the patient as-needed. 
     
     
         34 . A method for reducing alcohol consumption in a patient with alcohol dependence who maintains at least medium DRL after an observation period following initial assessment, which method comprises the administration of a therapeutically effective amount of nalmefene to said patient. 
     
     
         35 . The method according to  claim 34 , wherein said maintained DRL corresponds to consumption ≧40 g/day of pure alcohol for men and >20 g/day for women. 
     
     
         36 . The method according to  claim 34 , wherein the patient has a high DRL prior to the observation period and maintained a medium DRL after the observation period. 
     
     
         37 . The method according to  claim 34 , wherein the patient has a medium DRL prior to the observation period. 
     
     
         38 . The method according to  claim 34 , wherein said patient has a DRL prior to the observation period corresponding to consumption ≧60 g/day of pure alcohol for men and ≧40 g/day for women. 
     
     
         39 . The method according to  claim 34 , wherein said DRL is assessed by calculating mean daily alcohol consumption in g/day over a period preceding assessment, wherein said period is 1 week or longer. 
     
     
         40 . The method according to  claim 34 , wherein said DRL is assessed by calculating mean daily alcohol consumption in g/day over a period preceding assessment, wherein said period is 2 weeks or longer. 
     
     
         41 . The method according to  claim 34 , wherein nalmefene is administered in a dose of 10-20 mg. 
     
     
         42 . The method according to  claim 34 , where in nalmefene is administered for a treatment period of 6 -12 months. 
     
     
         43 . The method according to  claim 34 , wherein said nalmefene is administered to the patient as-needed. 
     
     
         44 . A method of reducing alcohol consumption in a patient who maintains at least medium DRL after an observation period in accordance with clinical practice, which method comprises the administration of a therapeutically effective amount of nalmefene to said patient. 
     
     
         45 . The method according to  claim 44 , wherein said maintained DRL corresponds to consumption ≧40 g/day of pure alcohol for men and ≧20 /day for women. 
     
     
         46 . The method according to  claim 44 , wherein the patient has a high DRL prior to the observation period and maintained a high DRL after the observation period. 
     
     
         47 . The method according to  claim 44 , wherein the patient has a medium DRL prior to the observation period. 
     
     
         48 . The method according to  claim 44 , wherein said patient has a DRL prior to the observation period corresponding to consumption >60 g/day of pure alcohol for men and ≧40 g/day for women. 
     
     
         49 . The method according to  claim 44 , wherein said DRL is assessed by calculating mean daily alcohol consumption in g/day over a period preceding assessment, wherein said period is 1 week or longer. 
     
     
         50 . The method according to  claim 44 , wherein said DRL is assessed by calculating mean daily alcohol consumption in g/day over a period preceding assessment, wherein said period is 2 weeks or longer. 
     
     
         51 . The method according to  claim 44 , wherein nalmefene is administered in a dose of 10-20 mg. 
     
     
         52 . The method according to  claim 44 , where in nalmefene is administered for a treatment period of 6 -12 months. 
     
     
         53 . The method according to  claim 44 , wherein said nalmefene is administered to the patient as-needed. 
     
     
         54 . A method for reducing of alcohol consumption in a patient with alcohol dependence, wherein said method comprises the following steps:
 a) identifying a patient with alcohol dependence 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 administered as-needed.   
     
     
         55 . The method according to  claim 54 , wherein nalmefene is administered on each day the patient perceives a risk of drinking alcohol. 
     
     
         56 . The method according to  claim 54 , wherein nalmefene is administered 1-2 hours prior to the anticipated time of drinking. 
     
     
         57 . The method according to  claim 54 , wherein said DRL is assessed by calculating mean daily alcohol consumption in g/day over a period preceding assessment, wherein said period is 1 week or longer.