NRx Pharmaceuticals, Inc. (NRXP) said Monday that the U.S. Food and Drug Administration has not identified any bioequivalence deficiencies in its Abbreviated New Drug Application for a preservative-free ketamine product, according to written correspondence from the agency.
The company said the feedback from the FDA's Office of Generic Drugs is preliminary and subject to final supervisory review, with a decision under the Generic Drug User Fee Amendments program expected in summer 2026.
NRx said its NRX-100, a preservative-free intravenous ketamine formulation, has been granted Fast Track designation for the treatment of suicidal ideation in depression, including bipolar depression. The company has filed an Abbreviated New Drug Application and has also initiated a New Drug Application filing for NRX-100, including an application for the Commissioner's National Priority Voucher Program.
The proposed product is the first ketamine formulation to be free of benzethonium chloride (BZT), a known toxic preservative. NRx said it expects the product to demonstrate up to three years of room-temperature stability and sterility, and has filed patent applications related to the formulation.
NRXP was up more than 2% in pre-market trading after closing at $2.08 on Monday.
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