- NRx Pharmaceuticals has filed a Citizen Petition with the FDA to remove benzethonium chloride from ketamine products.
- The preservative has known toxicity and is no longer allowed in hand sanitizers or topical antiseptics.
- Ketamine is increasingly used off-label for treating suicidal depression and PTSD.
- The company argues repeated exposure to benzethonium chloride through IV use poses unnecessary health risks.
- NRx has submitted data showing its preservative-free ketamine maintains sterility and stability for three years.
- The company is pursuing FDA approval for both its preservative-free ketamine (“NRX-100”) and oral NMDA-targeting drug (“NRX-101”).
NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, has submitted a formal Citizen Petition to the U.S. Food and Drug Administration (“FDA”), urging the agency to prohibit the use of benzethonium chloride in all ketamine products sold in the United States. According to the company, this chemical preservative presents known toxicity risks and is not Generally Recognized as Safe and Effective (“GRASE”) for pharmaceutical use in parenteral or topical formulations (https://ibn.fm/kYR0g).
Benzethonium chloride (“BZT”) is part of a broader class of quaternary ammonium preservatives linked to cellular and neurological toxicity. While previously used in a variety of over-the-counter products, the FDA has already removed BZT from hand cleansers and topical antiseptics, citing safety…
NOTE TO INVESTORS: The latest news and updates relating to NRXP are available in the company’s newsroom at https://ibn.fm/NRXP
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