Methods and compositions for the treatment of CNS-related conditions
DC CAFCFirst 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.
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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