NRX Pharmaceuticals Submits Real-World Data to FDA for Accelerated Approval of NRX-100

Reuters01-14

NRX Pharmaceuticals Submits Real-World Data to FDA for Accelerated Approval of NRX-100

NRX Pharmaceuticals, Inc. has announced the submission of Real World Evidence (RWE) from over 70,000 patients in support of its application for Accelerated Approval of NRX-100 (preservative-free ketamine) under Fast Track Designation for the treatment of suicidal ideation in depression and bipolar depression. The submission follows a recent policy change by the FDA allowing the inclusion of de-identified patient data in regulatory filings. Currently, there is no medicine approved specifically for the treatment of suicidal ideation, with Electroshock Therapy being the only FDA-approved intervention for this condition. The data, licensed from Osmind, will be presented to the FDA as part of the application process.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. NRX Pharmaceuticals Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9625501-en) on January 14, 2026, and is solely responsible for the information contained therein.

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