Compositions for the Treatment of CNS-Related Conditions

摘要

The invention provides methods for treating CNS-related conditions with amantadine and donepezil, in which the amantadine is in an extended release form, wherein the extended release amantadine formulation provides a change in plasma concentration as a function of time (dC/dT) that is less than 40% of the dC/dT of the same quantity of an immediate release form of amantadine.

主权项

1. A method of treating a CNS-related condition comprising orally administering once a day to a human subject in need thereof:
a. 200-500 mg amantadine or a pharmaceutically acceptable salt thereof provided in extended release dosage form, wherein said extended release amantadine or pharmaceutically acceptable salt thereof provides a change in plasma concentration as a function of time (dC/dT) that is less than 40% of the dC/dT of the same quantity of an immediate release form of amantadine, wherein dC/dT is measured in a single dose human PK study between the period of 0 to Tmax of the immediate release form of amantadine; and b. a therapeutically effective amount of donepezil or a pharmaceutically acceptable salt thereof, wherein the CNS-related condition is selected from a group consisting of Alzheimer's disease, dementia, Parkinson's disease, multiple sclerosis, traumatic brain injury, fatigue, and neuropsychiatric disorders.