Jan 19, 2016

The Human Experience with Intravenous Levodopa

Frontiers in Pharmacology
Shan H SiddiqiKevin J Black

Abstract

To compile a comprehensive summary of published human experience with levodopa given intravenously, with a focus on information required by regulatory agencies. While safe intravenous (IV) 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. Over 200 articles referring to IV levodopa were examined for details of administration, pharmacokinetics, benefit, and side effects. 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 2760 subjects have received IV levodopa, and reported outcomes include parkinsonian signs, sleep variables, hormone levels, hemodynamics, CSF amino acid composition, regional cerebral blood flow, cognition, perception and complex behavior. Mean pharmacokinetic variables were summarized for 49 healthy subjects and 190 with Parki...Continue Reading

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Citations

Mentioned in this Paper

Serum Hormone Levels (Lab Test)
United States Food and Drug Administration
Cerebral Blood Flow Imaging
Dopamine Agonists [MoA]
Research
Intravenous
Granulocyte Colony-Stimulating Factor
Administration Procedure
Adverse Effects
Blood Flow

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