Claims for Patent: 12,458,615

Summary for Patent: 12,458,615

Title:	Methods for providing rapid relief of motor fluctuations in a Parkinson's disease patient
Abstract:	The present invention provides methods of providing rapid relief of motor fluctuations in a Parkinson's disease patient. The methods of the invention comprise pulmonary administration of levodopa by inhalation at therapeutically effective concentrations such that the patient's plasma levodopa concentration increases by at least about 200 ng/ml within 10 minutes or less post inhalation as compared to the concentration of levodopa in the patient's plasma prior to inhalation of the levodopa and wherein the patient's plasma concentration remains increased by at least about 200 ng/ml for a time period of at least 15 minutes after inhalation. The methods of the invention are particularly useful for treatment of motor fluctuations which arise as a result of poorly controlled levodopa plasma levels in a patient.
Inventor(s):	Richard P. Batycky, Michael M. Lipp, Martin Freed
Assignee:	Merz Pharmaceuticals LLC
Application Number:	US18/949,037
Patent Claims:	1. A method of providing rapid relief of motor fluctuations in a Parkinson's disease patient comprising: administering at least one fine particle dose (FPD) of 20 mg to 50 mg of levodopa by inhalation to a Parkinson's disease patient, said FPD comprising 90% by dry weight levodopa, 8% by dry weight dipalmitoyl phosphatidylcholine (DPPC) and 2% by dry weight sodium chloride and the particles of the FPD having an aerodynamic diameter of less than 5.6 μm; wherein within about 10 minutes of administration of levodopa by inhalation, the patient's plasma levodopa concentration increases by at least about 200 ng/ml but no more than about 1000 ng/ml as compared to the patient's plasma levodopa concentration prior to administration; and wherein said patient's plasma levodopa concentration maintains said increase of at least about 200 ng/ml for a time period of at least about 15 minutes after administration. 2. The method of claim 1, wherein said Parkinson's disease patient is a stage 2, 3 or stage 4 Parkinson's disease patient. 3. The method of claim 1, wherein said dosages of levodopa are not affected by a central nervous system food effect. 4. The method of claim 1, wherein the patient's plasma levodopa concentration increases by at least 200 ng/ml for every 10 mg of levodopa delivered as compared to the patient's plasma levodopa concentration prior to administration of levodopa by inhalation. 5. The method of claim 1, wherein the method further comprises co-administering a dopa decarboxylase inhibitor to the patient, optionally wherein the dopa decarboxylase inhibitor is administered to the patient before, simultaneously with or after, administration of levodopa by inhalation. 6. The method of claim 4, wherein the method further comprises co-administering a dopa decarboxylase inhibitor to the patient, optionally wherein the dopa decarboxylase inhibitor is administered to the patient before, simultaneously with or after, administration of levodopa by inhalation. 7. The method of claim 1, wherein the patient's plasma levodopa concentration maintains said increase of at least about 200 ng/ml for a time period of at least 20 minutes after administration, at least 30 minutes after administration or at least 60 minutes after administration. 8. The method of claim 4, wherein the patient's plasma levodopa concentration maintains said increase of at least about 200 ng/ml for a time period of at least 20 minutes after administration, at least 30 minutes after administration or at least 60 minutes after administration. 9. The method of claim 1, wherein said patient's plasma levodopa concentration does not increase more than 1000 ng/ml within 10 minutes. 10. The method of claim 4, wherein said patient's plasma levodopa concentration does not increase more than 1000 ng/ml within 10 minutes. 11. The method of claim 1, wherein the patient's plasma levodopa levels increase by 200-500 ng/ml. 12. The method of claim 11, wherein said plasma levodopa levels are increased by 200-400 ng/ml, 300-400 ng/ml, 350-450 ng/ml or 400 ng/ml. 13. The method of claim 11, wherein said patient has at least a 100% improvement in UPDRS score within 20 minutes of administering said levodopa. 14. The method of claim 1, wherein said patient receives immediate relief of motor fluctuations within 10 minutes of said inhalation; and wherein said patient maintains said relief for a period of at least 30 minutes. 15. The method of claim 14, further comprising administering an oral dosage of levodopa to said patient. 16. The method of claim 14, wherein said relief of motor fluctuations is maintained for a period of at least 4 hours. 17. The method of claim 1, wherein the ratio of T1/2/Tmax is less than ½. 18. The method of claim 17, wherein said ratio is less than ⅕.