Levodopa formulations for rapid relief of Parkinson's disease

一种左旋多巴、帕金森病的技术，应用在用于快速缓解帕金森病的左旋多巴制剂领域，能够解决不良肠摄取等问题

Pending Publication Date: 2020-02-21
CIVITAS THERAPEUTICS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, patients are prone to problems involving gastric emptying and poor intestinal uptake of L-dopa

Method used

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  • Levodopa formulations for rapid relief of Parkinson's disease
  • Levodopa formulations for rapid relief of Parkinson's disease
  • Levodopa formulations for rapid relief of Parkinson's disease

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0101] overview

[0102] The 90 / 8 / 2 dry powder levodopa formulation is provided to evaluate the safety, tolerability, and Dopa Pharmacokinetics (PK). The pulmonary levodopa powder described in these examples consisted of 90% levodopa granules, 8% dipalmitoylphosphatidylcholine, and 2% sodium chloride (all on a dry basis) and is referred to herein as "90 / 8 / 2". This data provides an indication of the PK of levodopa following a single inhaled 90 / 8 / 2 dose, compared to oral levodopa (LD) administered under fasted and fed conditions, and with and without carbidol. Comparison of PK in the case of bar (CD) pretreatment. This was a two-part study in healthy adult male and female subjects, as follows: Part A - dose escalation segment compared to oral levodopa; and Part B - 90 / 8 / 2 plus or minus carb Dopa pretreatment link.

[0103] Part A is an open-label, 3-period crossover, single dose escalation study. Each subject received a single oral dose of CD / LD (25 / 100 mg) in the fed or...

Embodiment 2

[0193]A phase 2 study testing two doses of pulmonary levodopa (25 mg and 50 mg of study drug) was a multicentre, randomized, double-blind, placebo-controlled, single-dose, with three arms (placebo, 25 mg, and 50 mg ) and included an "open-label" oral Sinemet arm. Twenty-four (24) patients treated in this study were serially assessed for L-dopa plasma levels, exercise response, and safety at each visit. Patients in the off state are administered study drug and serial assessments begin prior to dosing and continue for up to 180 minutes after dosing. Motor function was assessed using the tap test, the Unified Parkinson's Disease Rating Scale Part III (UPDRS III), and subjective assessments of "meaningful" on and off. Safety parameters monitored included pulmonary function, clinical laboratory data, EGC, and vital signs (blood pressure, heart rate, and orthostatic blood pressure). This study was designed to measure the timing, magnitude, and persistence of pulmonary levodopa's e...

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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 comparedto 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.

Description

[0001] This application is a divisional application of the Chinese application whose filing date is October 21, 2013, application number is 201380067424.3 (PCT / US2013 / 065838), and the invention name is "Levodopa preparation for rapid relief of Parkinson's disease". [0002] related application [0003] This application claims U.S. Provisional Application No. 61 / 716,740, filed October 22, 2012, U.S. Provisional Application No. 61 / 813,605, filed April 18, 2013, and U.S. Provisional Application No. 61 / 813,725, filed April 19, 2013 rights and interests. The entire teaching of the above application is incorporated herein by reference. [0004] Background of the invention [0005] The neuropathology of Parkinson's disease is degeneration of dopamine neurons in the basal ganglia and is characterized neurologically by debilitating tremors, bradykinesia and balance problems. It is estimated that more than one million people are living with Parkinson's disease. Almost all patients rec...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/198A61K9/72A61K45/06A61K47/24A61P25/16
CPCA61K9/0075A61K9/0078A61K9/008A61K9/1617A61K31/198A61P25/16A61K45/06A61K2300/00A61K9/12A61K9/14A61K9/007A61K31/197
Inventor M·弗瑞德R·贝蒂凯M·M·利普
Owner CIVITAS THERAPEUTICS
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