Methods of administering amantadine
AssigneeAdamas Pharma, LLC
InventorsGregory T. Went, Timothy J. Fultz, Natalie McClure
Life of this patent
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Abstract
Methods of nighttime administration of amantadine to reduce sleep disturbances in patient undergoing treatment with amantadine are described, as well as compositions of extended release amantadine that are suitable for nighttime administration.
Claims58
A method of reducing OFF time and increasing ON time without troublesome dyskinesia in a patient with Parkinson's disease (PD), wherein the patient is being treated with levodopa, the method comprising:
- (1) orally administering to said patient once daily for at least one week a first composition comprising 85 mg to 170 mg amantadine, or a pharmaceutically acceptable salt thereof, and at least one excipient that modifies the release of at least a portion of the amantadine or pharmaceutically acceptable salt thereof to provide an extended release form;
- and thereafter
- (2) orally administering to said patient once daily a second composition comprising about 260 mg to 380 mg amantadine, or a pharmaceutically acceptable salt thereof, and at least one excipient that modifies the release of at least a portion of the amantadine or pharmaceutically acceptable salt thereof to provide an extended release form;
- wherein OFF time is reduced and ON time without troublesome dyskinesia is increased after at least 7 weeks of administering the second composition once daily to the patient;
- and
- wherein the plasma concentration of amantadine in the patient is increased less than 10% at 1 hour after administration of the second composition.
A method of reducing OFF time and increasing ON time without troublesome dyskinesia in a patient with Parkinson's disease (PD), wherein the patient is being treated with levodopa, the method comprising:
- (1) orally administering to said patient once daily for at least one week a first composition comprising 260 mg amantadine hydrochloride and at least one excipient that modifies the release of at least a portion of the amantadine hydrochloride to provide an extended release form;
- and thereafter
- (2) orally administering to said patient once daily a second composition comprising 290 mg to 325 mg amantadine hydrochloride and at least one excipient that modifies the release of at least a portion of the amantadine hydrochloride to provide an extended release form;
- wherein OFF time is reduced and ON time without troublesome dyskinesia is increased after at least 7 weeks of administering the second composition once daily to the patient;
- and
- wherein the plasma concentration of amantadine in the patient is increased less than 10% at 1 hour after administration of second composition.
Dependencies are inferred from the claim text.