Aug 18, 2015

The human experience with intravenous levodopa

BioRxiv : the Preprint Server for Biology
Shan H SiddiqiKevin J Black

Abstract

Objective: To compile a comprehensive summary of published human experience with levodopa given intravenously, with a focus on information required by regulatory agencies. Background: While safe intravenous use of levodopa has been documented for over 50 years, regulatory supervision for pharmaceuticals given by a route other than that approved by the U.S. Food and Drug Administration (FDA) has become increasingly cautious. If delivering a drug by an alternate route raises the risk of adverse events, an investigational new drug (IND) application is required, including a comprehensive review of toxicity data. Methods: Over 200 articles referring to intravenous levodopa (IVLD) were examined for details of administration, pharmacokinetics, benefit and side effects. Results: We identified 142 original reports describing IVLD use in humans, beginning with psychiatric research in 1959-1960 before the development of peripheral decarboxylase inhibitors. At least 2781 subjects have received IVLD, and reported outcomes include parkinsonian signs, sleep variables, hormones, hemodynamics, CSF amino acid composition, regional cerebral blood flow, cognition, perception and complex behavior. Mean pharmacokinetic variables were summarized for ...Continue Reading

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Mentioned in this Paper

United States Food and Drug Administration
Cerebral Blood Flow Imaging
Dopamine Agonists [MoA]
Research
Intravenous
Granulocyte Colony-Stimulating Factor
Administration Procedure
Adverse Effects
Down Syndrome
Blood Flow

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