COMPOSITION AND METHOD FOR TREATING NEUROLOGICAL DISEASE
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.
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.