Claims for Patent: 8,329,752

Summary for Patent: 8,329,752

Title:	Composition for administering an NMDA receptor antagonist to a subject
Abstract:	The invention provides compostions for administering memantine to a subject. Memantine in an extended release form containing 22.5 to 30 mg memantine or a pharmaceutically acceptable salt achieves particular pharmacokinetic criteria such as change in plasma concentration of memantine over time and ratio of maximum memantine plasma concentration to mean memantine plasma concentration.
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:	13/536,008
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,329,752
Patent Claims:	1. A solid pharmaceutical composition in a unit dosage form for oral administration comprising an extended release formulation of 22.5 mg to 30 mg memantine or a pharmaceutically acceptable salt thereof, wherein administration of a dose of the composition to a human subject provides a mean plasma memantine concentration profile characterized by a change in concentration of memantine as a function of time (dC/dT) that is: (a) less than about 50% of the dC/dT provided by the same quantity of an immediate release form of memantine, determined in a time period between 0-Tmax of the immediate release form of memantine; and (b) 2.1 ng/ml/hr or less, determined in a time period of 0 to 4 hours; wherein dC/dT is measured in a single-dose human PK study. 2. The composition of claim 1, wherein the dC/dT of 2.1 ng/ml/hr or less is determined in a time period of 2 to 4 hours. 3. The composition of claim 1, comprising 25 mg to 30 mg memantine or a pharmaceutically acceptable salt thereof. 4. The composition of claim 3, wherein the dC/dT of 2.1 ng/ml/hr or less is determined in a time period of 2 to 4 hours. 5. The composition of claim 1, comprising 25 mg to 28 mg memantine or a pharmaceutically acceptable salt thereof. 6. The composition of claim 5, wherein the dC/dT of 2.1 ng/ml/hr or less is determined in a time period of 2 to 4 hours. 7. The composition of claim 1, comprising 28 mg memantine or a pharmaceutically acceptable salt thereof. 8. The composition of claim 7, wherein the dC/dT of 2.1 ng/ml/hr or less is determined in a time period of 2 to 4 hours. 9. A solid pharmaceutical composition in a unit dosage form for oral administration comprising an extended release formulation of 22.5 mg to 30 mg memantine or a pharmaceutically acceptable salt thereof, wherein administration of a dose of the composition to a human subject provides a mean plasma memantine concentration profile characterized by a change in concentration of memantine as a function of time (dC/dT) that is: (a) less than about 50% of the dC/dT provided by the same quantity of an immediate release form of memantine, determined in a time period between 0 hours and 6 hours of administration of memantine; and (b) 2.1 ng/ml/hr or less, determined in a time period of 0 to 4 hours; wherein dC/dT is measured in a single-dose human PK study. 10. The composition of claim 9, wherein the dC/dT of 2.1 ng/ml/hr or less is determined in a time period of 2 to 4 hours. 11. The composition of claim 9, comprising 25 mg to 30 mg memantine or a pharmaceutically acceptable salt thereof. 12. The composition of claim 11, wherein the dC/dT of 2.1 ng/ml/hr or less is determined in a time period of 2 to 4 hours. 13. The composition of claim 9, comprising 25 mg to 28 mg memantine or a pharmaceutically acceptable salt thereof. 14. The composition of claim 13, wherein the dC/dT of 2.1 ng/ml/hr or less is determined in a time period of 2 to 4 hours. 15. The composition of claim 9, comprising 28 mg memantine or a pharmaceutically acceptable salt thereof. 16. The composition of claim 15, wherein the dC/dT of 2.1 ng/ml/hr or less is determined in a time period of 2 to 4 hours.