# US 10,500,170 B2 · Composition and method for treating neurological disease > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,500,170 B2 - Document ID: US10500170B2 - Status: Granted - Kind: B2 - Application number: 16/241,631 - Filed: 2019-01-07 - Published: 2019-08-15 - Granted: 2019-12-10 - Earliest claimed: 2018-02-15 - Assignees: Osmotica Kereskedelmi és Szolgáltató Korlátolt Felelõsségû Társaság - Applicants: Osmotica Kereskedelmi és Szolgáltató Korlátolt Felelõsségû Társaság - Inventors: Glenn A. Meyer; Joaquina Faour; Ana Cristina Pastini; Marcelo Fernando Befumo - Web page: https://patentgrep.com/patent/US10500170B2 ## CPC - A61K 31/13: Amines {(A61K31/04 takes precedence)} - A61K 9/0004: {Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas} - A61K 9/20: Pills, tablets, {discs, rods (A61K9/0004, A61K9/0007, A61K9/0056, A61K9/0065 take precedence; for reconstitution of a drink A61K9/0095)} - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61P 25/16: Anti-Parkinson drugs - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## 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. ## Claims ### Claim 1 A method of treating Parkinson's disease in a patient, comprising administering to the patient a pharmaceutical composition comprising i) an osmotic agent and amantadine or a pharmaceutically acceptable salt thereof in an extended release form, and ii) amantadine or a pharmaceutically acceptable salt thereof in an immediate release form, wherein the composition comprises 258 mg of amantadine free base equivalent, and wherein the mean steady-state Cavg of the composition is at least 95% of the mean steady-state Cavg provided by the same daily quantity of amantadine or a pharmaceutically acceptable salt thereof in an immediate release form. ### Claim 2 (depends on 1) The method of claim 1, wherein the mean steady-state Cavg of the composition is at least 97% of the mean steady-state Cavg provided by the same daily quantity of amantadine or a pharmaceutically acceptable salt thereof in an immediate release form. ### Claim 3 (depends on 2) The method of claim 2, wherein the pharmaceutically acceptable salt thereof is amantadine HCl. ### Claim 4 (depends on 1) The method of claim 1, wherein the pharmaceutical composition is an osmotic device. ### Claim 5 (depends on 4) The method of claim 4, wherein the osmotic device comprises a semipermeable membrane. ### Claim 6 (depends on 1) The method of claim 1, wherein the mean steady-state Cavg for the composition is about 947 ng/mL. ### Claim 7 A method of treating Parkinson's disease in a patient, comprising administering to the patient a pharmaceutical composition comprising i) an osmotic agent and amantadine or a pharmaceutically acceptable salt thereof in an extended release form, and ii) amantadine or a pharmaceutically acceptable salt thereof in an immediate release form, wherein the composition comprises 258 mg of amantadine free base equivalent, and wherein the steady-state AUC0-24 for the composition is at least 95% of the steady-state AUC0-24 provided by the same daily quantity of amantadine or a pharmaceutically acceptable salt thereof in an immediate release form. ### Claim 8 (depends on 7) The method of claim 7, wherein the steady-state AUC0-24 for the composition is at least 97% of the steady-state AUC0-24 provided by the same daily quantity of amantadine or a pharmaceutically acceptable salt thereof in an immediate release form. ### Claim 9 (depends on 8) The method of claim 8, wherein the pharmaceutically acceptable salt thereof is amantadine HCl. ### Claim 10 (depends on 7) The method of claim 7, wherein the pharmaceutical composition is an osmotic device. ### Claim 11 (depends on 10) The method of claim 10, wherein the osmotic device comprises a semipermeable membrane. ### Claim 12 (depends on 7) The method of claim 7, wherein the steady-state AUC0-24 for the composition is about 22,737 ng·h/mL. ### Claim 13 A method of treating Parkinson's disease in a patient, comprising administering to the patient a pharmaceutical composition comprising i) an osmotic agent and amantadine or a pharmaceutically acceptable salt thereof in an extended release form, and ii) amantadine or a pharmaceutically acceptable salt thereof in an immediate release form, wherein the composition comprises 258 mg of amantadine free base equivalent, and wherein the steady-state Cmax of the composition is comparable to the steady-state Cmax provided by the same daily quantity of amantadine or a pharmaceutically acceptable salt thereof in an immediate release form. ### Claim 14 (depends on 13) The method of claim 13, wherein the pharmaceutically acceptable salt thereof is amantadine HCl. ### Claim 15 (depends on 13) The method of claim 13, wherein the pharmaceutical composition is an osmotic device. ### Claim 16 (depends on 15) The method of claim 15, wherein the osmotic device comprises a semipermeable membrane. ### Claim 17 (depends on 13) The method of claim 13, wherein the steady-state Cmax0-24 of the composition is about 1275 ng/mL. ### Claim 18 A method of treating Parkinson's disease in a patient, comprising administering to the patient a pharmaceutical composition comprising i) an osmotic agent and amantadine or a pharmaceutically acceptable salt thereof in an extended release form, and ii) amantadine or a pharmaceutically acceptable salt thereof in an immediate release form, wherein the composition comprises 258 mg of amantadine free base equivalent, and wherein steady-state is achieved by about Day 6. ### Claim 19 (depends on 18) The method of claim 18, wherein at steady-state the plasma concentration of the composition is at least 85% of the concentration provided by the same daily quantity of amantadine or a pharmaceutically acceptable salt thereof in an immediate release form. ### Claim 20 (depends on 18) The method of claim 18, wherein the pharmaceutically acceptable salt thereof is amantadine HCl. ### Claim 21 (depends on 18) The method of claim 18, wherein the pharmaceutical composition is an osmotic device. ### Claim 22 (depends on 21) The method of claim 21, wherein the osmotic device comprises a semipermeable membrane. ### Claim 23 (depends on 18) The method of claim 18, wherein at steady-state the plasma concentration of the composition is between about 609 and about 662 ng/mL.