NRx Pharmaceuticals, Inc. announced the filing of a Citizen Petition with the U.S. Food and Drug Administration (FDA), seeking the removal of Benzethonium Chloride (BZT) from all forms of ketamine sold in the United States. BZT is a preservative with known toxicity, not Generally Recognized as Safe (GRAS) for parenteral products.
BZT belongs to a class of quaternary amine preservatives known to be toxic to epithelial cells and to demonstrate neurotoxicity, having been removed from many eyedrops due to demonstrated toxicity. The FDA no longer allows BZT in hand cleansers and topical antiseptics.
Dr. Jonathan Javitt, CEO of NRx Pharmaceuticals, stated that patients receiving repeated intravenous ketamine are exposed to this known toxic preservative. NRx has already filed an Abbreviated New Drug Application (ANDA) for a preservative-free ketamine preparation and a patent on its preservative-free process, positioning its NRX-100 as a potentially safer alternative.
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