Methods and compositions for the treatment of CNS-related conditions
DC CAFC
First Claim
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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.
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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.
153 Citations
15 Claims
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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:
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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. - View Dependent Claims (2, 3, 4, 5, 6)
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7. A method of treating a CNS-related condition comprising orally administering once a day to a human subject in need thereof:
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(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. - View Dependent Claims (8, 9, 10, 11, 12, 13, 14, 15)
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Specification
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Litigation Data
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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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Primary Examiner(s)Padmanabhan, Sreeni
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Assistant Examiner(s)Carter, Kendra D
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Application NumberUS12/757,795Publication NumberTime in Patent Office914 DaysField of Search514/597, 514/766, 424/400US Class Current514/597CPC Class CodesA61K 2300/00 Mixtures or combinations of...A61K 31/13 Amines A61K31/04 takes prec...A61K 31/445 Non condensed piperidines, ...A61K 45/06 Mixtures of active ingredie...A61K 9/0053 Mouth and digestive tract, ...A61K 9/1635 obtained by reactions only ...A61K 9/1652 Polysaccharides, e.g. algin...A61K 9/20 Pills, tablets, discs, rods...A61K 9/2009 Inorganic compoundsA61K 9/2013 Organic compounds, e.g. pho...A61K 9/2054 Cellulose; Cellulose deriva...A61K 9/2059 Starch, including chemicall...A61K 9/2813 Inorganic compoundsA61K 9/282 Organic compounds, e.g. fatsA61K 9/48 Preparations in capsules, e...A61K 9/4808 characterised by the form o...A61K 9/7061 PolyacrylatesA61P 25/00 Drugs for disorders of the ...A61P 25/04 Centrally acting analgesics...A61P 25/16 Anti-Parkinson drugsView All
