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Claims for Patent: 8,283,379

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Claims for Patent: 8,283,379

Title:Methods and compositions for the treatment of CNS-related conditions
Abstract: The present invention provides novel methods and compositions for the treatment and prevention of CNS-related conditions. One of the CNS-related conditions treated by the methods and compositions of the invention is Alzheimer's disease.
Inventor(s): Went; Gregory T. (Mill Valley, CA), Fultz; Timothy J. (Pleasant Hill, CA), Meyerson; Laurence R. (Las Vegas, NV)
Assignee: Adamas Pharmaceuticals, Inc. (Emeryville, CA)
Application Number:12/757,795
Patent Claims: 1. A method of reducing the potential for an adverse effect in a human subject being treated for a CNS-related condition comprising orally administering once a day to a human subject in need thereof a pharmaceutical composition comprising: 5 to 40 mg memantine or a pharmaceutically acceptable salt thereof in an extended release dosage form, wherein said extended release memantine or pharmaceutically acceptable salt thereof provides a change in plasma concentration as a function of time (dC/dT) in the defined time period of 0 to 6 hours after administration, as measured in a single-dose human PK study, that is less than about 50% of the dC/dT provided by the same quantity of an immediate release form of memantine in said defined time period; wherein the adverse effect is related to memantine; and wherein the CNS-related condition is selected from the group consisting of Alzheimer's disease and dementia.

2. The method of claim 1, wherein the dosage form comprises 12.5-40 mg of memantine or salt thereof.

3. The method of claim 1, wherein the dosage form comprises 25-40 mg of memantine or salt thereof.

4. The method of claim 1, wherein the extended release dosage form further comprises, ethyl cellulose, polyethylene glycol, hydroxypropylmethyl cellulose and polyvinylpyrrolidone.

5. The method of claim 1, wherein said extended release memantine or a pharmaceutically acceptable salt thereof has an in vitro dissolution profile of less than 60% in four hours and less than 80% in six hours as measured using a USP type 2 (paddle) dissolution system at 50 rpm, at a temperature of 37.+-.0.5.degree. C. with water as a dissolution medium.

6. The method of claim 1, wherein the extended release dosage form is co-administered with an AChEI, selected from the group consisting of donepezil, galantamine, rivastigmine and tacrine.

7. A method of treating a CNS-related condition comprising orally administering once a day to a human subject in need thereof: (a) 5 to 40 mg memantine or a pharmaceutically acceptable salt thereof provided in an extended release dosage form, wherein said extended release memantine or pharmaceutically acceptable salt thereof provides a change in plasma concentration as a function of time (dC/dT) in the defined time period of 0 to 6 hours after administration as measured in a single-dose human PK study that is less than about 50% of the dC/dT provided by the same quantity of an immediate release form of memantine in said defined time period; and (b) a therapeutically effective amount of an AChEI, or a pharmaceutically acceptable salt thereof, wherein the CNS-related condition is selected from the group consisting of Alzheimer's disease and dementia.

8. The method of claim 7, wherein said memantine or a pharmaceutically acceptable salt thereof and said AChEI or a pharmaceutically acceptable salt thereof are administered simultaneously.

9. The method of claim 7, wherein said memantine or a pharmaceutically acceptable salt thereof and said AChEI or a pharmaceutically acceptable salt thereof are administered as a single composition.

10. The method of claim 7, wherein said AChEI is selected from the group consisting of donepezil, rivastigmine, galantamine and tacrine.

11. The method of claim 7, wherein said AChEI is donepezil.

12. The method of claim 7, wherein the dosage form comprises 12.5-40 mg of memantine or salt thereof.

13. The method of claim 7, wherein the dosage form comprises 25-40 mg of memantine or salt thereof.

14. The method of claim 7, wherein the extended release dosage form further comprises, ethyl cellulose, polyethylene glycol, hydroxypropylmethyl cellulose and polyvinylpyrrolidone.

15. The method of claim 7, wherein said extended release memantine or a pharmaceutically acceptable salt thereof has an in vitro dissolution profile of less than 60% in four hours and less than 80% in six hours as measured using a USP type 2 (paddle) dissolution system at 50 rpm, at a temperature of 37.+-.0.5.degree. C. with water as a dissolution medium.
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