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US 10,500,172 B2Granted
Composition and method for treating neurological disease
AssigneeOsmotica Kereskedelmi és Szolgáltató Korlátolt Felelõsségû Társaság
InventorsGlenn A. Meyer, Joaquina Faour, Ana Cristina Pastini, Marcelo Fernando Befumo
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Abstract
The present disclosure is directed to methods of treating neurological disorders in a patient such as Parkinson's disease, drug-induced extrapyramidal reactions, and/or levodopa-induced dyskinesia comprising administering to the patient once daily in the morning a pharmaceutical composition comprising about 50 mg to about 400 mg of extended-release amantadine or a pharmaceutically acceptable salt thereof.
Claims29
A method of treating a drug-induced extrapyramidal reaction in an adult patient, comprising:
- i) administering to the patient once daily in the morning a pharmaceutical composition comprising about 129 mg of amantadine free base equivalent for about one week;
- ii) increasing the dose of amantadine by administering to the patient once daily in the morning a pharmaceutical composition comprising about 193 mg of amantadine free base equivalent;
- wherein each of the pharmaceutical compositions comprises i) an extended release component comprising amantadine free base equivalent;
- and ii) an immediate release component comprising about 48 mg of amantadine free base equivalent;
- wherein each of the pharmaceutical compositions is a solid oral dosage form,
- wherein the maximum daily dose of amantadine is about 322 mg of amantadine free base equivalent,
- wherein the mean Cmax of the pharmaceutical composition comprising about 129 mg of amantadine free base equivalent after a single-dose administration is between about 50% and about 125% of the mean Cmax provided by the same quantity of amantadine or a pharmaceutically acceptable salt thereof in an immediate release form;
- and
- wherein the mean Cmax of the pharmaceutical composition comprising about 193 mg of amantadine free base equivalent after a single-dose administration is between about 50% and about 175% of the mean Cmax provided by the same quantity of amantadine or a pharmaceutically acceptable salt thereof in an immediate release form.
6 more elements
A method of treating a drug-induced extrapyramidal reaction in an adult patient, comprising:
- i) administering to the patient once daily in the morning a pharmaceutical composition comprising about 129 mg of amantadine free base equivalent for about one week;
- ii) increasing the dose of amantadine by administering to the patient once daily in the morning a pharmaceutical composition comprising about 193 mg of amantadine free base equivalent;
- wherein each of the pharmaceutical compositions comprises i) an extended release component comprising amantadine free base equivalent;
- and ii) an immediate release component comprising about 48 mg of amantadine free base equivalent,
- wherein each of the pharmaceutical compositions is a solid oral dosage form,
- wherein the maximum daily dose of amantadine is about 322 mg of amantadine free base equivalent,
- wherein the mean AUC0-∞ of the pharmaceutical composition comprising about 129 mg of amantadine free base equivalent after a single-dose administration is between 65% and about 135% of the mean AUC0-∞ provided by the same quantity of amantadine or a pharmaceutically acceptable salt thereof in an immediate release form, and
- wherein the mean AUC0-∞ of the pharmaceutical composition comprising about 193 mg of amantadine free base equivalent after a single-dose administration is between 85% and about 225% of the mean AUC0-∞ provided by the same quantity of amantadine or a pharmaceutically acceptable salt thereof in an immediate release form.
5 more elements
A method of treating a drug-induced extrapyramidal reaction in an adult patient, comprising:
- i) administering to the patient once daily in the morning a pharmaceutical composition comprising about 129 mg of amantadine free base equivalent for about one week;
- ii) increasing the dose of amantadine by administering to the patient once daily in the morning a pharmaceutical composition comprising about 193 mg of amantadine free base equivalent for at least one week;
- iii) increasing the dose of amantadine by administering to the patient once daily in the morning a pharmaceutical composition comprising about 258 mg of amantadine free base equivalent;
- wherein each of the pharmaceutical compositions comprises i) an extended release component comprising amantadine free base equivalent;
- and ii) an immediate release component comprising about 48 mg of amantadine free base equivalent,
- wherein each of the pharmaceutical compositions is a solid oral dosage form,
- wherein the maximum daily dose of amantadine is about 322 mg of amantadine free base equivalent,
- wherein the mean Cmax of the pharmaceutical composition comprising about 129 mg of amantadine free base equivalent after a single-dose administration is between about 50% and about 125% of the mean Cmax provided by the same quantity of amantadine or a pharmaceutically acceptable salt thereof in an immediate release form,
- wherein the mean Cmax of the pharmaceutical composition comprising about 193 mg of amantadine free base equivalent after a single-dose administration is between about 50% and about 175% of the mean Cmax provided by the same quantity of amantadine or a pharmaceutically acceptable salt thereof in an immediate release form, and
- wherein the mean Cmax of the pharmaceutical composition comprising about 258 mg of amantadine free base equivalent after a single-dose administration is between about 95% and about 250% of the mean Cmax provided by the same quantity of amantadine or a pharmaceutically acceptable salt thereof in an immediate release form.
7 more elements
A method of treating a drug-induced extrapyramidal reaction in an adult patient, comprising:
- i) administering to the patient once daily in the morning a pharmaceutical composition comprising about 129 mg of amantadine free base equivalent for about one week;
- ii) increasing the dose of amantadine by administering to the patient once daily in the morning a pharmaceutical composition comprising about 193 mg of amantadine free base equivalent for at least one week;
- iii) increasing the dose of amantadine by administering to the patient once daily in the morning a pharmaceutical composition comprising about 258 mg of amantadine free base equivalent;
- wherein each of the pharmaceutical compositions comprises i) an extended release component comprising amantadine free base equivalent;
- and ii) an immediate release component comprising about 48 mg of amantadine free base equivalent,
- wherein each of the pharmaceutical compositions is a solid oral dosage form,
- wherein the maximum daily dose of amantadine is about 322 mg of amantadine free base equivalent,
- wherein the mean AUC0-∞ of the pharmaceutical composition comprising about 129 mg of amantadine free base equivalent after a single-dose administration is between 65% and about 135% the mean AUC0-∞ provided by the same quantity of amantadine or a pharmaceutically acceptable salt thereof in an immediate release form,
- wherein the mean AUC0-∞ of the pharmaceutical composition comprising about 193 mg of amantadine free base equivalent after a single-dose administration is between 85% and about 225% the mean AUC0-∞ provided by the same quantity of amantadine or a pharmaceutically acceptable salt thereof in an immediate release form, and
- wherein the mean AUC0-∞ of the pharmaceutical composition comprising about 258 mg of amantadine free base equivalent after a single-dose administration is between about 130% and about 290% of the mean AUC0-∞ provided by the same quantity of amantadine or a pharmaceutically acceptable salt thereof in an immediate release form.
7 more elements
Dependencies are inferred from the claim text.