Composition and method for treating neurological disease
View Patent ↗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 mg 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 50% of the drug in the dose is in an extended release form, and wherein the dose provides a mean change in amantadine plasma concentration as a function of time (dC/dT) as measured in a single dose human pharmacokinetic study over the time period between 2 hours and 4 hours after administration that is less than 30% of the dC/dT provided by the same quantity of the drug in an immediate release form as measured in a single dose human pharmacokinetic study over the time period between 0 and 2 hours after administration.
2. The method of claim 1 , wherein the amount of drug is 300 to 500 mg.
3. The method of claim 1 , wherein at least 75% of the drug in the dose is in an extended release form.
4. The method of claim 1 , wherein the dose additionally comprises the drug in an immediate release form.
5. The method of claim 1 , wherein at least 90% of the drug in the dose is in an extended release form.
6. The method of claim 1 , wherein the dose administered is therapeutically effective for the treatment of Parkinson's disease.
7. The method of claim 1 , wherein the human subject with Parkinson's disease suffers from dyskinesia.
8. The method of claim 7 , wherein the method reduces the frequency or severity of dyskinesia.
9. The method of claim 7 , wherein the dyskinesia is levodopa-induced dyskinesia.
10. The method of claim 1 , additionally comprising administering to the subject a pharmaceutically effective amount of levodopa/carbidopa.
11. The method of claim 1 , 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 , wherein the dose comprises an osmotic device which utilizes an osmotic driving force to provide extended release of the drug.
13. The method of claim 1 , wherein the extent of drug bioavailability is maintained.
14. The method of claim 1 , wherein the once-daily dose is administered at a therapeutically-effective dose from the onset of therapy.