# US 2023/0053976 A1 · Rapid relief of motor fluctuations in parkinson's disease > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2023/0053976 A1 - Document ID: US20230053976A1 - Status: Published application - Kind: A1 - Application number: 17/584,663 - Filed: 2022-01-26 - Published: 2023-02-23 - Earliest claimed: 2017-01-31 - Assignees: Civitas Therapeutics, Inc. - Applicants: Civitas Therapeutics, Inc. - Inventors: Richard P. Batycky; Martin Freed; Michael M. Lipp - Web page: https://patentgrep.com/patent/US20230053976A1 ## CPC - A61K 31/198: Alpha-amino acids, e.g. alanine or edetic acid [EDTA] (betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00) - A61K 9/0075: {for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles} - 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 invention provides methods for treating OFF episodes in a Parkinson's Disease patient comprising administering levodopa to the pulmonary system of a patient wherein after administration, the patient's Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 score is improved by, for example, at least about 5 points as compared to placebo control and/or as compared to the patient's UDPRS Part 3 score prior to administration. The invention also provides methods of reducing mean daily OFF time in a Parkinson's patient. ## Claims ### Claim 1 A method for treating OFF episodes in a Parkinson's Disease (PD) patient comprising administering levodopa to the pulmonary system of a patient wherein after administration, the patient's Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 score is improved by at least 5 points as compared to placebo control. ### Claim 2 (depends on 1) The method of claim 1, wherein the patient's UPDRS Part 3 score is improved by at least 5 to 10 points as compared to placebo control. ### Claim 3 (depends on 1) The method of claim 1, wherein the patient is administered about 30 mg to about 60 mg fine particle dose (FPD) of levodopa to the pulmonary system. ### Claim 4 (depends on 1) The method of claim 1, wherein the patient is administered 35 mg or 50 mg FPD of levodopa. ### Claim 5 (depends on 1) The method of claim 1, wherein the patient does not experience increased dyskinesis as compared to the level of dyskinesis prior to pulmonary administration of said levodopa. ### Claim 6 (depends on 1) The method of claim 1, wherein the patient has about 3 to about 4 OFF episodes a day. ### Claim 7 (depends on 1) The method of claim 1, wherein the patient has about 4 to about 8 hours of OFF episodes a day. ### Claim 8 (depends on 1) The method of claim 1, wherein the patient's UPDRS Part 3 score is improved by at least 5 to 10 points as compared to placebo control within 60 minutes following administration of said FPD of levodopa. ### Claim 9 (depends on 1) The method of claim 1, wherein the contents of at least one capsule containing said FPD of levodopa is administered to the patient via inhalation. ### Claim 10 (depends on 9) The method of claim 9, wherein the contents of at least two capsules comprising said FPD of levodopa is administered to the patient via inhalation. ### Claim 11 (depends on 9) The method of claim 9, wherein the fine particle dose of levodopa is delivered from said at least one capsule to the pulmonary system by an inhalation device. ### Claim 12 (depends on 11) The method of claim 11, wherein the inhalation device is a dry powder inhaler (DPI) or a metered-dose inhaler (MDI). ### Claim 13 (depends on 1) The method of claim 1, wherein said administration occurs at the emergence of OFF symptoms. ### Claim at position 14 14-26. (canceled) ### Claim 27 A method for reducing the mean daily OFF time in a Parkinson's Disease patient comprising administering levodopa to the pulmonary system of a patient at least twice a day wherein the patient's mean daily OFF time is reduced by at least one hour. ### Claim 28 (depends on 27) The method of claim 27, wherein the patient's mean daily OFF time is reduced by at least 3 hours. ### Claim 29 (depends on 27) The method of claim 27, wherein the patient is administered about 30 mg to about 60 mg fine particle dose (FPD) of levodopa to the pulmonary system. ### Claim 30 (depends on 27) The method of claim 27, wherein the patient is administered 35 mg or 50 mg FPD of levodopa. ### Claim 31 (depends on 27) The method of claim 27, wherein the patient does not experience increased dyskinesis as compared to the level of dyskinesis prior to pulmonary administration of said levodopa. ### Claim 32 (depends on 27) The method of claim 27, wherein the patient has about 3 to about 4 OFF episodes a day. ### Claim 33 (depends on 27) The method of claim 27, wherein the patient has about 4 to about 8 hours of OFF episodes a day. ### Claim at position 22 34-47. (canceled)