NRx Pharmaceuticals (NASDAQ:NRXP) achieved a pivotal regulatory milestone Wednesday, announcing the submission of a massive real-world dataset to the U.S. Food and Drug Administration (FDA) to support the accelerated approval of NRX-100, its proprietary preservative-free ketamine.
The submission, drawn from over 70,000 patients, represents one of the largest clinical datasets ever compiled for the use of ketamine in treating suicidal ideation and depression.
The data, provided through a strategic partnership with the neuropsychiatry platform Osmind, captures nearly one million treatment sessions.
It includes granular longitudinal safety and efficacy metrics, such as continuous vitals monitoring and specialized assessments of bladder health and sedation—data points often missing from smaller clinical trials.
The submission was made possible by a landmark September 2025 FDA policy shift, which eased restrictions on using de-identified real-world evidence (RWE) in drug applications.
Previously, the agency required patient-identifiable data, a high bar that made large-scale medical record databases impractical for regulatory use.
This common-sense reform, championed by FDA Commissioner Marty Makary, aims to unlock insights from massive registries to bring life-saving treatments to market faster.
Preliminary analyses of a 20,000-patient subset previously presented to the American Society of Clinical Psychopharmacology suggested a favorable clinical response compared to currently approved antidepressants.
NRX-100 is specifically formulated without the preservative benzethonium chloride, which is present in generic ketamine but has never been evaluated for safety in the repeated doses required for psychiatric care.
NRx is pursuing Accelerated Approval under a Fast Track Designation.
If granted, NRX-100 would be the first standalone pharmacological treatment for acute suicidal crisis in patients with Major Depressive Disorder and Bipolar Depression.
The company expects the full analysis of the 70,000-patient dataset to be a cornerstone of its New Drug Application (NDA), potentially shortening the timeline for a commercial launch in late 2026.