NRx Pharmaceuticals announced that it has licensed real-world evidence drawn from over 70,000 patients treated with intravenous ketamine or nasal S-ketamine for depression and suicidal ideation, data to be submitted in support of the company’s Accelerated Approval application for NRX-100, a preservative-free ketamine formulation. NRX-100 has been granted Fast Track Designation by the FDA for treating suicidal ideation in patients with depression and bipolar depression. Currently, no medicine is approved specifically to treat suicidal ideation; electroshock therapy is the only FDA-approved treatment available for this indication.
The real-world evidence is provided by Osmind, a neuropsychiatry technology platform used by clinics across the United States. The dataset includes nearly one million treatment sessions with ketamine or esketamine, hundreds of millions of datapoints of continuous vitals monitored during treatment, and specialized data elements such as assessment of bladder symptoms and sedation. A preliminary analysis of a subset of 20,000 patients was presented at the 2024 meeting of the American Society of Clinical Psychopharmacology, documenting rapid resolution of depression and suicidality with intravenous ketamine initiation and showing clinical response consistent with prior randomized trials and comparing favorably to currently-approved products.
Jonathan Javitt, MD, MPH, Chairman and CEO of NRx Pharmaceuticals, noted that an American commits suicide every 11 minutes and that ketamine has become widely used off-label for reducing suicidal ideation. He emphasized that currently, only Americans whose care is paid for by the military and Veterans Administration, along with those who can pay out of pocket, are able to access this potentially valuable medicine. In September 2025, the FDA altered its policy to allow submission of real-world evidence that does not include personally-identifiable patient information, enabling the submission of Osmind’s de-identified data.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.benzinga.com/pressreleases/26/01/g49900556/nrx-pharmaceuticals-nasdaq-nrxp-announces-70-000-patient-data-on-real-world-use-of-ketamine-for-tr