METHOD FOR ADMINISTERING AN NMDA RECEPTOR ANTAGONIST TO A SUBJECT
First Claim
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1. A method of treating a patient with a neurological disorder, comprising:
- administering to said subject once daily a sustained release oral dosage form comprising 22.5 mg to 30 mg of memantine or a pharmaceutically acceptable salt thereof and a component that sustains release of said memantine or salt thereof,wherein said sustained release memantine provides a change in mean plasma 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.
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Abstract
The invention provides methods for administering memantine to a subject. Memantine in an extended release form containing 22.5 to 30 mg memantine or a pharmaceutically acceptable salt is administered to a patient suffering from a neurological condition, such as Alzheimer'"'"'s disease, Parkinson'"'"'s disease or dementia. The extended release form 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.
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Citations
30 Claims
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1. A method of treating a patient with a neurological disorder, comprising:
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administering to said subject once daily a sustained release oral dosage form comprising 22.5 mg to 30 mg of memantine or a pharmaceutically acceptable salt thereof and a component that sustains release of said memantine or salt thereof, wherein said sustained release memantine provides a change in mean plasma 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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
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13. A method of treating a patient with a neurological disorder, comprising:
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administering to said subject once daily a sustained release oral dosage form comprising 22.5 mg to 30 mg of memantine or a pharmaceutically acceptable salt thereof and a component that sustains release of said memantine or salt thereof, wherein said sustained release memantine provides a change in mean plasma 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. - View Dependent Claims (14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24)
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25. A method of treating a patient with a neurological disorder, comprising:
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administering to said subject once daily a sustained release oral dosage form comprising 22.5 mg to 30 mg of memantine or a pharmaceutically acceptable salt thereof and a component that sustains release of said memantine or salt thereof, wherein administration of a dose of the composition to a human subject provides a plasma memantine concentration profile, as measured in a single-dose human PK study, characterized by a memantine concentration Cmax/Cmean of about 2 as measured over a time period of 2 to 8 hours. - View Dependent Claims (26, 27, 28, 29, 30)
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Specification
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Current AssigneeAdamas Pharma, LLC (Supernus Pharmaceuticals, Inc.)
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Original AssigneeAdamas Pharmaceuticals, Inc. (Supernus Pharmaceuticals, Inc.)
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InventorsWent, Gregory T., Fultz, Timothy J., Meyerson, Laurence R.
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Granted Patent
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Time in Patent OfficeDays
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Field of Search
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US Class Current514/662
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CPC Class CodesA61K 31/13 Amines A61K31/04 takes prec...A61K 9/4891 Coated capsules; Multilayer...A61P 25/00 Drugs for disorders of the ...A61P 25/02 for peripheral neuropathiesA61P 25/04 Centrally acting analgesics...A61P 25/08 Antiepileptics; Anticonvuls...A61P 25/16 Anti-Parkinson drugsA61P 25/24 AntidepressantsA61P 25/28 for treating neurodegenerat...A61P 25/30 for treating abuse or depen...
