Method of administering amantadine prior to a sleep period
AssigneeAdamas Pharma, LLC
InventorsGregory T. Went, Gayatri Sathyan, Kavita Vermani, Gangadhara Ganapati, Michael Coffee, Efraim Shek, Ashok Katdare
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.
Claims56
A method of administering a dose of a pharmaceutical composition of a drug selected from the group consisting of amantadine and pharmaceutically acceptable salts thereof to a human patient in need thereof, comprising administering said dose of said pharmaceutical composition to said human patient orally, once daily 0 to 4 hours before bedtime, wherein said dose of said pharmaceutical composition comprises:
- (i) 250 mg to 600 mg of the drug;
- and (ii) one or more excipients, wherein at least one of said one or more excipients modifies the release of said drug to provide an extended release dosage form, and
- wherein when said pharmaceutical composition is dosed in a single dose, fasted, human pharmacokinetic study in healthy subjects, the fractional AUC0-4 for amantadine is less than 5% of AUC0-inf and the Tmax of amantadine is 8 to 20 hours.
A method of administering a dose of a pharmaceutical composition of a drug selected from the group consisting of amantadine and pharmaceutically acceptable salts thereof to a human patient in need thereof, comprising administering said dose of said pharmaceutical composition to said human patient orally, once daily 0 to 4 hours before bedtime, wherein said dose of said pharmaceutical composition comprises:
- (i) 250 mg to 600 mg of the drug;
- and (ii) one or more excipients, wherein at least one of said one or more excipients modifies the release of said drug to provide an extended release dosage form, and
- wherein when said pharmaceutical composition is dosed in a single dose, fasted, human pharmacokinetic study in healthy subjects, the fractional AUC0-8 for amantadine is 5% to 15% of AUC0-inf and the Tmax for amantadine is 8 to 20 hours.
A method of administering a dose of a pharmaceutical composition of a drug selected from the group consisting of amantadine and pharmaceutically acceptable salts thereof to a human patient in need thereof, comprising administering said dose of said pharmaceutical composition to said human patient orally, once daily 0 to 4 hours before bedtime, wherein said dose of said pharmaceutical composition comprises:
- (i) 250 mg to 600 mg of the drug;
- and (ii) one or more excipients, wherein at least one of said one or more excipients modifies the release of said drug to provide an extended release dosage form, and
- wherein when said pharmaceutical composition is dosed in a single dose, fasted, human pharmacokinetic study in healthy subjects, the fractional AUC0-4 for amantadine is less than 5% of AUC0-inf and the Cmax for amantadine is 1.0 to 2.4 ng/ml per mg of amantadine.
A method of administering a dose of a pharmaceutical composition of a drug selected from the group consisting of amantadine and pharmaceutically acceptable salts thereof to a human patient in need thereof, comprising administering said dose of said pharmaceutical composition to said human patient orally, once daily 0 to 4 hours before bedtime, wherein said dose of said pharmaceutical composition comprises:
- (i) 250 mg to 600 mg of the drug;
- and (ii) one or more excipients, wherein at least one of said one or more excipients modifies the release of said drug to provide an extended release dosage form, and
- wherein when said pharmaceutical composition is dosed in a single dose, fasted, human pharmacokinetic study in healthy subjects, the fractional AUC0-8 for amantadine is 5% to 15% of AUC0-inf and the Cmax for amantadine is 1.0 to 2.4 ng/ml per mg of amantadine.
Dependencies are inferred from the claim text.