Composition and method for treating neurological disease

Abstract

Disclosed are compositions comprising amantadine, or a pharmaceutically acceptable salt thereof, and one or more excipients, wherein at least one of the excipients modifies release of amantadine. Methods of administering the same are also provided.

What is claimed is: 
     
         1 . A method comprising:
 orally administering to a human subject with Parkinson's disease a once daily dose consisting of (i) 200 to 500 mg of a drug selected from the group consisting of amantadine and pharmaceutically acceptable salts thereof, and (ii) at least one excipient,
 wherein at least one of said excipients is a release modifying excipient, and 
 wherein at least 50% of said drug is in an extended release form, and 
 wherein administration of the dose once daily provides a steady state plasma concentration of about 3 μM. 
   
     
     
         2 . A method comprising:
 orally administering to a human subject with Parkinson's disease a once daily dose consisting of (i) 200 to 500 mg of a drug selected from the group consisting of amantadine and pharmaceutically acceptable salts thereof, and (ii) at least one excipient,
 wherein at least one of said excipients is a release modifying excipient, and 
 wherein at least 50% of said drug is in an extended release form, and 
 wherein administration of the dose once daily provides a steady state plasma concentration of about 0.5 μg/ml. 
   
     
     
         3 . The method of  claim 1  or  2 , wherein at least 75% of the drug in the dose is in an extended release form. 
     
     
         4 . The method of  claim 1  or  2 , wherein at least 90% of the drug in the dose is in an extended release form. 
     
     
         5 . The method of  claim 1  or  2 , wherein at least some of the drug in the dose is in an immediate release form. 
     
     
         6 . The method of  claim 1  or  2 , wherein the amount of drug is 300 mg to 500 mg. 
     
     
         7 . The method of  claim 1  or  2 , wherein the dose is therapeutically effective for the treatment of Parkinson's disease. 
     
     
         8 . The method of  claim 1  or  2 , wherein the human subject with Parkinson's disease suffers from dyskinesia. 
     
     
         9 . The method of  claim 1  or  2 , wherein the dyskinesia is levodopa-induced dyskinesia. 
     
     
         10 . The method of  claim 1  or  2 , additionally comprising administering to the subject a pharmaceutically effective amount of levodopa/carbidopa. 
     
     
         11 . The method of  claim 1  or  2 , wherein the dose provides a shift in amantadine Tmax of 2 hours to 16 hours relative to an immediate release form of amantadine, wherein the Tmax is measured in a single dose human pharmacokinetic study. 
     
     
         12 . The method of  claim 1  or  2 , wherein the extended release form comprises an osmotic device which utilizes an osmotic driving force to provide extended release of the drug. 
     
     
         13 . The method of  claim 1  or  2 , wherein the extent of drug bioavailability is maintained. 
     
     
         14 . The method of  claim 1  or  2 , wherein the once-daily dose is administered at a therapeutically-effective dose from the onset of therapy.