Claims for Patent: 10,500,171

Summary for Patent: 10,500,171

Title:	Composition and method for treating neurological disease
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.
Inventor(s):	Meyer; Glenn A. (Wilmington, NC), Faour; Joaquina (Ciudad Autonoma de Beunos Aires, AR), Pastini; Ana Cristina (Ciudad Autonoma de Buenos Aires, AR), Befumo; Marcelo Fernando (Ciudad Autonoma de Buenos Aires, AR)
Assignee:	Osmotica Kereskedelmi es SzolgaltatoKorlatolt Felelossegu Tarsasag (Budapest, HU)
Application Number:	16/241,636
Patent Claims:	1. A method of a drug-induced extrapyramidal reaction in an adult 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 C.sub.avg of the composition is at least 95% of the mean steady-state C.sub.avg provided by the same daily quantity of amantadine or a pharmaceutically acceptable salt thereof in an immediate release form. 2. The method of claim 1, wherein the mean steady-state C.sub.avg of the composition is at least 97% of the mean steady-state C.sub.avg provided by the same daily quantity of amantadine or a pharmaceutically acceptable salt thereof in an immediate release form. 3. The method of claim 2, wherein the pharmaceutically acceptable salt thereof is amantadine HCl. 4. The method of claim 1, wherein the pharmaceutical composition is an osmotic device. 5. The method of claim 4, wherein the osmotic device comprises a semipermeable membrane. 6. The method of claim 1, wherein the mean steady-state C.sub.avg for the composition is about 947 ng/mL. 7. A method of treating a drug-induced extrapyramidal reaction in an adult 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 AUC.sub.0-24 for the composition is at least 95% of the steady-state AUC.sub.0-24 provided by the same daily quantity of amantadine or a pharmaceutically acceptable salt thereof in an immediate release form. 8. The method of claim 7, wherein the steady-state AUC.sub.0-24 for the composition is at least 97% of the steady-state AUC.sub.0-24 provided by the same daily quantity of amantadine or a pharmaceutically acceptable salt thereof in an immediate release form. 9. The method of claim 8, wherein the pharmaceutically acceptable salt thereof is amantadine HCl. 10. The method of claim 7, wherein the pharmaceutical composition is an osmotic device. 11. The method of claim 10, wherein the osmotic device comprises a semipermeable membrane. 12. The method of claim 7, wherein the steady-state AUC.sub.0-24 for the composition is about 22,737 ngh/mL. 13. A method of treating a drug-induced extrapyramidal reaction in an adult 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 C.sub.max of the composition is comparable to the steady-state C.sub.max provided by the same daily quantity of amantadine or a pharmaceutically acceptable salt thereof in an immediate release form. 14. The method of claim 13, wherein the pharmaceutically acceptable salt thereof is amantadine HCl. 15. The method of claim 13, wherein the pharmaceutical composition is an osmotic device. 16. The method of claim 15, wherein the osmotic device comprises a semipermeable membrane. 17. The method of claim 13, wherein the steady-state C.sub.max0-24 of the composition is about 1275 ng/mL. 18. A method of treating a drug-induced extrapyramidal reaction in an adult 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. 19. 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. 20. The method of claim 18, wherein the pharmaceutically acceptable salt thereof is amantadine HCl. 21. The method of claim 18, wherein the pharmaceutical composition is an osmotic device. 22. The method of claim 21, wherein the osmotic device comprises a semipermeable membrane. 23. The method of claim 18, wherein at steady-state the plasma concentration of the composition is between about 609 and about 662 ng/mL.