WILMINGTON, DE — NRx Pharmaceuticals, Inc. said it has secured Fast Track designation from the U.S. Food and Drug Administration for NRX-100, a preservative-free ketamine formulation aimed at treating suicidal ideation in patients with depression and bipolar depression, a condition for which no drug therapy is currently approved.
The company disclosed that it has licensed regulatory-grade real-world evidence drawn from more than 70,000 U.S. patients treated with either intravenous ketamine or nasal S-ketamine. The data are being submitted to the U.S. Food and Drug Administration in support of an application for Accelerated Approval under the Fast Track program.
The real-world dataset is being supplied by Osmind, a nationwide neuropsychiatry technology and electronic medical records platform used by clinics across the country. According to the companies, the evidence aligns with FDA guidance and includes longitudinal safety and effectiveness data derived from nearly one million ketamine or esketamine treatment sessions.
NRx said earlier analyses of a 20,000-patient subset showed rapid reductions in depression severity and suicidal ideation following initiation of intravenous ketamine. Those findings, previously presented at the 2024 meeting of the American Society of Clinical Psychopharmacology, suggested outcomes consistent with prior randomized trials and compared favorably with currently approved products.
The full dataset spans hundreds of millions of monitored data points, including continuous vital signs and differentiated safety indicators such as sedation levels and bladder-related symptoms. Results from the complete 70,000-patient analysis are expected to be submitted to the FDA as part of the company’s Accelerated Approval effort.
In September 2025, the FDA revised its policy to permit the submission of de-identified real-world evidence that does not include personally identifiable patient information, a change that enabled Osmind’s data to be used in regulatory filings.
NRx Chairman and Chief Executive Officer Jonathan Javitt said the company is seeking to address a significant treatment gap. He noted that ketamine is already widely used off label and has been adopted within military and veterans communities, but access remains limited for patients whose insurance does not reimburse its use.
Fast Track designation is intended to speed the development and review of drugs that address serious conditions and unmet medical needs. If approved, NRX-100 would represent the first FDA-cleared pharmacologic treatment specifically indicated for suicidal ideation, potentially reshaping clinical options in acute mental health care.
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