Curated News
By: NewsRamp Editorial Staff
August 22, 2025
NRx Petitions FDA to Ban Toxic Ketamine Preservative for Patient Safety
TLDR
- NRx Pharmaceuticals seeks FDA ban on toxic ketamine preservative, positioning its safer NRX-100 as the superior treatment option for depression and PTSD.
- NRx Pharmaceuticals filed a Citizen Petition with FDA data showing preservative-free ketamine maintains sterility and stability for three years without benzethonium chloride risks.
- Removing toxic preservatives from ketamine treatments improves patient safety and advances mental healthcare for those suffering from depression and PTSD.
- Ketamine used for depression may contain a toxic preservative banned from hand sanitizers, prompting NRx to develop a safer alternative.
Impact - Why it Matters
This news matters because ketamine has emerged as a crucial treatment for severe mental health conditions like treatment-resistant depression and PTSD, particularly for patients at immediate risk of suicide. The presence of benzethonium chloride in some ketamine formulations represents a significant patient safety concern, as this preservative has documented toxicity issues and has already been banned from other medical products. For patients receiving regular ketamine treatments, repeated exposure to toxic preservatives could cause additional health complications while they're already vulnerable. The push for preservative-free alternatives ensures that mental health treatments don't introduce new risks while trying to alleviate suffering, potentially setting a new safety standard for all psychedelic and psychiatric medications.
Summary
NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, has taken a significant step in patient safety by filing a formal Citizen Petition with the U.S. Food and Drug Administration. The company is urging the FDA to prohibit the use of benzethonium chloride in all ketamine products sold in the United States, arguing that this chemical preservative presents known toxicity risks and is not Generally Recognized as Safe and Effective for pharmaceutical use. This move comes as ketamine is increasingly used off-label for treating serious mental health conditions including suicidal depression and PTSD, making the safety of its formulation critically important.
The company highlights that benzethonium chloride, part of a broader class of quaternary ammonium preservatives linked to cellular and neurological toxicity, has already been removed from hand cleansers and topical antiseptics by the FDA due to safety concerns. NRx Pharmaceuticals contends that repeated exposure to this preservative through intravenous use poses unnecessary health risks to patients. In support of their petition, the company has submitted compelling data showing that its preservative-free ketamine formulation maintains sterility and stability for an impressive three years, demonstrating that safe alternatives are readily available.
This development is particularly significant as NRx Pharmaceuticals pursues FDA approval for both its preservative-free ketamine (designated as "NRX-100") and its oral NMDA-targeting drug ("NRX-101"). The company's proactive stance on removing toxic preservatives from ketamine products reflects growing concerns within the medical community about medication safety, especially for vulnerable patient populations. For those interested in following this developing story, additional information is available through the InvestorBrandNetwork and PsychedelicNewsWire platforms that cover pharmaceutical and psychedelic sector developments.
Source Statement
This curated news summary relied on content disributed by InvestorBrandNetwork (IBN). Read the original source here, NRx Petitions FDA to Ban Toxic Ketamine Preservative for Patient Safety
