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Generated: August 21, 2017

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Title:Method and composition for administering an NMDA receptor antagonist to a subject
Abstract: The invention provides methods and compositions for administering an NMDA receptor antagonist (e.g., memantine) to a subject.
Inventor(s): Went; Gregory T. (Mill Valley, CA), Fultz; Timothy J. (Pleasant Hill, CA), Porter; Seth (San Carlos, CA), Meyerson; Laurence R. (Las Vegas, NV), Burkoth; Timothy S. (San Francisco, CA)
Assignee: Adamas Pharmaceuticals, Inc. (Emeryville, CA)
Filing Date:Oct 28, 2011
Application Number:13/284,630
Claims:1. A method of administering memantine to a human subject in need thereof, comprising: orally administering to the subject once per day over multiple days a sustained release oral dosage form comprising memantine or a pharmaceutically acceptable salt thereof and a component that sustains release of the memantine or the salt thereof; wherein a daily dose of 12.5 to 40 mg of memantine or pharmaceutically acceptable salt thereof is administered from the initiation of therapy without prior dose escalation of memantine; wherein such administration results in the subject achieving a therapeutically effective steady state memantine plasma concentration within 20 days after initiation of therapy with said dosage form; and wherein the subject has a condition selected from the group consisting of Alzheimer's disease, dementia, Parkinson's disease and neuropathic pain.

2. The method of claim 1, wherein said sustained release memantine provides a change in plasma concentration as a function of time (dC/dT) in a 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.

3. The method of claim 1, wherein said sustained release memantine provides a change in plasma concentration as a function of time (dC/dT) that is less than about 50% of the dC/dT provided by the same quantity of an immediate release form of memantine, wherein the dC/dT is measured in a single dose human PK study between the time period of 0 to Tmax of the immediate release form of memantine.

4. The method of claim 1, wherein the dosage form has a memantine in vitro dissolution profile ranging between 0.1-20% in one hour, 5-30% in two hours, 40-80% in six hours, and 50 to 90% in 10 hours, wherein the dissolution profile is determined using a USP type 2 (paddle) dissolution system at 50 rpm, at a temperature of 37.+-.0.5.degree. C., in 500 ml water.

5. The method of claim 1, wherein said subject has not been administered memantine or a pharmaceutically acceptable salt thereof within one week prior to the initiation of therapy with said sustained release oral dosage form.

6. A method of administering memantine to a human subject in need thereof, comprising: orally administering to the subject once per day over multiple days a sustained release oral dosage form comprising memantine or a pharmaceutically acceptable salt thereof and a component that sustains release of the memantine or the salt thereof; wherein 12.5 to 40 mg of memantine or pharmaceutically acceptable salt thereof is administered daily from the initiation of therapy without prior dose escalation of memantine; wherein daily administration of 12.5 to 40 mg of memantine or pharmaceutically acceptable salt thereof results in the subject achieving a therapeutically effective steady state memantine plasma concentration within 20 days after initiation of therapy with said dosage form; and wherein the subject has a condition selected from the group consisting of Alzheimer's disease, dementia, Parkinson's disease and neuropathic pain.

7. The method of claim 6, wherein said sustained release memantine provides a change in plasma concentration as a function of time (dC/dT) in a 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.

8. The method of claim 6, wherein said sustained release memantine provides a change in plasma concentration as a function of time (dC/dT) that is less than about 50% of the dC/dT provided by the same quantity of an immediate release form of memantine, wherein the dC/dT is measured in a single dose human PK study between the time period of 0 to Tmax of the immediate release form of memantine.

9. The method of claim 6, wherein the dosage form has a memantine in vitro dissolution profile ranging between 0.1-20% in one hour, 5-30% in two hours, 40-80% in six hours, and 50 to 90% in 10 hours, wherein the dissolution profile is determined using a USP type 2 (paddle) dissolution system at 50 rpm, at a temperature of 37.+-.0.5.degree. C., in 500 ml water.

10. The method of claim 6, wherein said subject has not been administered memantine or a pharmaceutically acceptable salt thereof within one week prior to the initiation of therapy with said sustained release oral dosage form.
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