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Last Updated: April 12, 2025

Claims for Patent: 11,439,613

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Summary for Patent: 11,439,613

Title:	Levodopa fractionated dose composition and use
Abstract:	There is provided a convenient new treatment of Parkinson disease by a frequent administration of optimal levodopa doses mimicking a continuous intravenous or infusion treatment, thus mitigating motor complications; and a new carbidopa/levodopa pharmaceutical unit form providing said new treatment.
Inventor(s):	Chase Thomas N, Clarence-Smith Kathleen E.
Assignee:	AVION PHARMACEUTICALS. LLC
Application Number:	US17219253
Patent Claims:	1. A method for the treatment of Parkinson's disease or related levodopa (LD)-responsive disorders , comprising orally administering to a patient in need thereof , carbidopa/levodopa (CD/LD) at an effective dose to simulate continuous intravenous administration of LD , up to 9 times per day ,wherein the effective dose comprises CD within a range of 6.25 mg to 18.75 mg and LD within a range of 25 mg to 75 mg, andwherein entacapone is not concurrently administered.2. The method of claim 1 , wherein the effective dose comprises CD within a range of 6.25 mg to 8.3 mg and LD within a range of 25 mg to 33.3 mg.3. The method of claim 1 , wherein the patient is administered from one to six unit doses as the effective dose claim 1 , each unit dose comprising a carbidopa/levodopa amount selected from the group consisting of carbidopa-6.25 mg/levodopa-25 mg and carbidopa-8.3 mg/levodopa-33.3 mg.4. The method of claim 1 , wherein said patient is a newly diagnosed patient at the initial stage of Parkinson's disease.5. The method of claim 1 , wherein said patient is a parkinsonian patient previously administered a standard treatment with carbidopa/levodopa (CD/LD).6. The method of claim 5 , wherein said patient suffers from motor response complications.7. The method of claim 1 , wherein the effective dose is administered from 5 to 9 times per day.8. The method of claim 7 , wherein the effective dose is administered from 5 to 6 times per day.9. The method of claim 1 , wherein the effective dose to simulate continuous intravenous administration of LD provides a constant plasma concentration range of the LD for full efficacy with no motor response complications.10. The method of claim 1 , wherein the blood plasma concentration range of LD in the patient is within a physiologic range in comparison to when the patient is not treated with the effective dose of CD/LD.11. A method for the treatment of Parkinson's disease or levodopa (LD)-responsive disorders in a patient who is hypersensitive to LD claim 1 , comprising orally administering to the patient claim 1 , carbidopa/levodopa (CD/LD) at an effective dose to simulate continuous intravenous administration of LD claim 1 , up to 9 times per day claim 1 ,wherein the effective dose comprises CD within a range of 6.25 mg to 18.75 mg and LD within a range of 25 mg to 75 mg, andwherein entacapone is not concurrently administered.12. The method of wherein the effective dose comprises CD within a range of 6.25 mg to 8.3 mg and LD within a range of 25 mg to 33 mg.13. The method of claim 11 , wherein the patient is administered from one to six unit doses as the effective dose claim 11 , each unit dose comprising a carbidopa/levodopa amount selected from the group consisting of carbidopa-6.25 mg/levodopa-25 mg and carbidopa-8.3 mg/levodopa-33.3 mg.14. The method of claim 11 , wherein the patient is a minor child.15. The method of claim 11 , wherein the LD-responsive disorder is generalized dystonia.16. The method of claim 11 , wherein the effective dose is administered two times a day (b.i.d.) or three times a day (t.i.d.).17. The method of claim 11 , wherein the effective dose comprises a carbidopa/levodopa amount of carbidopa-12.5 mg/levodopa-50 mg claim 11 , and the effective dose is administered two times a day (b.i.d.).18. A method of treating claim 11 , alleviating claim 11 , or delaying the onset of claim 11 , motor response complications related to Parkinson's disease or related levodopa (LD)-responsive disorder claim 11 , comprising orally administering to a patient in need thereof claim 11 , carbidopa/levodopa (CD/LD) at an effective dose to simulate continuous intravenous administration of LD claim 11 , up to 9 times per day claim 11 ,wherein the effective dose comprises CD within a range of 6.25 mg to 18.75 mg and LD within a range of 25 mg to 75 mg, andwherein entacapone is not concurrently administered.19. The method of claim 18 , wherein the effective dose comprises CD within a range of 6.25 mg to 8.3 mg and LD within a range of 25 mg to 33. mg.20. The method of claim 18 , wherein the patient is administered from one to six unit doses as the effective dose claim 18 , each unit dose comprising a carbidopa/levodopa amount selected from the group consisting of carbidopa-6.25 mg/levodopa-25 mg and carbidopa-8.3 mg/levodopa-33.3 mg.21. The method of claim 18 , wherein the effective dose is administered from 5 to 9 times per day.22. The method of claim 21 , wherein the effective dose is administered from 5 to 6 times per day.23. The method of claim 18 , wherein the effective dose to simulate continuous intravenous administration of LD provides a constant plasma concentration range of the LD for full efficacy with no motor response complications.24. The method of claim 1 , wherein the effective dose to simulate continuous intravenous administration of LD provides a constant plasma concentration range of the LD for full efficacy with reduced motor response complications in comparison to when the patient is not treated with the effective dose of CD/LD.25. The method of claim 11 , wherein the effective dose to simulate continuous intravenous administration of LD provides a constant plasma concentration range of the LD for full efficacy with reduced motor response complications in comparison to when the patient is not treated with the effective dose of CD/LD.26. The method of claim 6 , wherein said method relieves said motor response complications.27. The method of claim 1 , wherein said method delays the onset of motor response complications.28. The method of claim 1 , wherein the effective dose comprises CD 6.25 mg and LD 75 mg.29. The method of claim 1 , wherein the effective dose comprises CD 8.3 mg and LD 33.3 mg.

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