11:15 AM EDT, 09/24/2025 (MT Newswires) -- NRX Pharmaceuticals ( NRXP ) said Wednesday it received notification from the US Food and Drug Administration that its suitability petition for a preservative-free ketamine product has been approved, clearing the way to re-file an Abbreviated New Drug Application for the single-patient formulation, Ketafree.

The petition allows the company to pursue an alternative to ketamine products currently sold in multi-dose vials containing Benzethonium Chloride, a preservative it described as toxic.

The company said the preservative-free formulation aligns with federal priorities to reshore critical drug production and to eliminate harmful additives from foods and medicines.

NRX said it expects Ketafree to compete in the $750 million ketamine market, alongside separate plans to advance NRX-100 as a potential treatment for suicidal depression and PTSD.

Shares of NRX Pharmaceuticals ( NRXP ) were up 7% in recent trading.

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