NRx Pharmaceuticals Advances Dual Regulatory Strategy for Preservative-Free Ketamine Therapies

NRx Pharmaceuticals Inc. (NASDAQ: NRXP) is advancing a two-pronged regulatory approach to bring preservative-free ketamine-based therapies to market, addressing both existing approved indications and novel treatment applications. The company recently refiled an Abbreviated New Drug Application for KETAFREE(TM), a preservative-free intravenous ketamine formulation intended for all currently approved ketamine indications. This filing follows the U.S. Food and Drug Administration's approval of NRx's Suitability Petition to eliminate benzethonium chloride, a chemical preservative still found in many ketamine formulations.

Benzethonium chloride, a quaternary ammonium compound, has been associated with cytotoxic and neurotoxic effects and is no longer considered Generally Recognized as Safe and Effective for parenteral or topical pharmaceutical use. The European Medicines Agency has already discouraged its use in injectable drugs, and the FDA previously removed it from topical antiseptics and hand cleansers over safety concerns. By developing KETAFREE(TM), NRx aims to provide a safer and fully compliant version of ketamine for both hospital and outpatient use at a time when supply constraints and rising demand have challenged healthcare providers.

Alongside the ANDA pathway for KETAFREE(TM), NRx is advancing NRX-100, a separate preservative-free ketamine product, under a New Drug Application for the treatment of suicidal depression, including bipolar depression. The formulation has been granted Fast Track Designation by the FDA, positioning it for potential expedited review. NRx has recently initiated a New Drug Application filing for NRX-100 for the treatment of suicidal depression based on results of well-controlled clinical trials conducted under the auspices of the U.S. National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement.

The company's dual regulatory strategy represents a comprehensive approach to addressing both immediate market needs through the ANDA pathway while pursuing innovative treatment applications through the NDA process. This approach comes at a critical time when ketamine therapies are gaining broader acceptance in medical practice, yet safety concerns about existing formulations persist. The company's progress can be tracked through its corporate communications available at https://ibn.fm/NRXP, while broader industry developments are covered by specialized financial communications platforms such as https://www.InvestorWire.com.