RAPID RELIEF OF MOTOR FLUCTUATIONS IN PARKINSON'S DISEASE
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.
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.
2 . 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.
3 . 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.
4 . The method of claim 1 , wherein the patient is administered 35 mg or 50 mg FPD of levodopa.
5 . 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.
6 . The method of claim 1 , wherein the patient has about 3 to about 4 OFF episodes a day.
7 . The method of claim 1 , wherein the patient has about 4 to about 8 hours of OFF episodes a day.
8 . 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.
9 . 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.
10 . 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.
11 . 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.
12 . The method of claim 11 , wherein the inhalation device is a dry powder inhaler (DPI) or a metered-dose inhaler (MDI).
13 . The method of claim 1 , wherein said administration occurs at the emergence of OFF symptoms.
14 - 26 . (canceled)
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.
28 . The method of claim 27 , wherein the patient's mean daily OFF time is reduced by at least 3 hours.
29 . 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.
30 . The method of claim 27 , wherein the patient is administered 35 mg or 50 mg FPD of levodopa.
31 . 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.
32 . The method of claim 27 , wherein the patient has about 3 to about 4 OFF episodes a day.
33 . The method of claim 27 , wherein the patient has about 4 to about 8 hours of OFF episodes a day.
34 - 47 . (canceled)