NRx Pharmaceuticals Petitions FDA to Ban Benzethonium Chloride from Ketamine Products

NRx Pharmaceuticals has filed a Citizen Petition with the FDA to remove Benzethonium Chloride from all ketamine products in the US, citing toxicity concerns. The company is pursuing a labeled indication for suicidal depression and has submitted an Abbreviated New Drug Application for a preservative-free ketamine formulation with three-year room temperature stability and sterility. The FDA has designated ketamine as a Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain.

Title: NRx Pharmaceuticals Secures FDA Fast Track Designation for NRX-100

NRx Pharmaceuticals Inc. (NASDAQ: NRXP) has received a significant regulatory milestone from the FDA, granting Fast Track designation for NRX-100, its intravenous ketamine treatment for suicidal ideation in patients with depression, including bipolar depression. This designation, announced on August 11, 2025, represents a substantial expansion of the addressable population and accelerates the regulatory pathway for NRx's suicide treatment.

The Fast Track designation for NRX-100 covers suicidal ideation across all depression types, not just bipolar depression, thereby expanding the potential market from approximately 1.3 million Americans to 13 million annually. This 10-fold increase in the addressable population positions NRx to disrupt the $3+ billion market for suicidal depression treatment in the US [1].

Clinical trials supporting this designation demonstrated robust efficacy, with a 55% response rate in suicidal patients compared to 30% for active comparators, and 63% achieving full remission from suicidal ideation within three days versus 31% for placebo [2]. The company estimates a market opportunity of $3+ billion, addressing approximately 13 million Americans who consider suicide annually.

NRX-100 is the first preservative-free ketamine formulation filed with the FDA, offering potential three-year room temperature shelf life. The company has completed CMC information filing and is pursuing a Commissioner's National Priority Voucher (CNPV) to expedite review. The FDA's determination that NRX-100 addresses an unmet medical need is particularly significant, as it satisfies a crucial requirement for the CNPV program and potentially Accelerated Approval, which could dramatically compress the approval timeline.

The company's preservative-free formulation provides a competitive advantage over existing ketamine products containing Benzethonium Chloride (BZT). NRx has established US-based manufacturing and submitted complete CMC information, positioning them to capture a share of the estimated $3+ billion market for suicidal depression treatment in the US.

The Fast Track designation unlocks massive market opportunity addressing 13 million potential patients in the underserved suicide prevention market. NRx's Fast Track designation unlocks massive market opportunity addressing 13 million potential patients in the underserved suicide prevention market. With US-based manufacturing already established and Fast Track benefits accelerating their timeline, NRx has positioned itself to potentially capture first-mover advantage in what has been an underserved market despite the enormous public health impact of suicide.

References
[1] https://www.stocktitan.net/news/NRXP/n-rx-pharmaceuticals-inc-nasdaq-nrxp-granted-fda-fast-track-ayetxan1s6b6.html
[2] https://www.biospace.com/press-releases/nrx-pharmaceuticals-inc-nasdaq-nrxp-granted-fda-fast-track-designation-for-nrx-100-for-suicidal-ideation-in-patients-with-depression-including-bipolar-depression