GlobeNewswire·Oct 30, 2026, 7:00 AM ET

NRx Pharmaceuticals (Nasdaq:NRXP) Receives FDA Approval of Preservative-Free Ketamine Ahead of November 10 FDA Goal Date

NRXP

The FDA approved NRx Pharmaceuticals' Abbreviated New Drug Application (ANDA) for Preservative-Free Ketamine on October 30, 2026, ahead of the November 10 goal date.
This formulation eliminates Benzethonium Chloride (BZT), a toxic preservative banned by the FDA from new drugs, hand cleansers, wipes, and intravenous formulations due to its lack of GRAS status.
NRx Pharmaceuticals manufactured the sterile injectable drug in West Columbia, South Carolina, using modern blow-fill-seal technology in partnership with Nephron Pharmaceuticals.
The approval addresses the ongoing shortage of traditional glass-bottled ketamine, which has been on the FDA drug shortage list since 2018.
NRx filed a Citizen Petition with the FDA to remove BZT from ketamine, supported by a toxicology report indicating current dosages may exceed the FDA's maximum daily exposure limit of 1 milligram.
Jonathan Javitt, MD, MPH, the company's Chairman and CEO, stated the product allows for repeat treatments without the dangers associated with the banned preservative.
The drug is primarily used for anesthesia and pain control, including in labor and delivery, where it is the only IV anesthetic that minimizes breathing suppression in babies.
NRx is a clinical-stage biopharmaceutical company developing therapeutics for depression, PTSD, and suicidality based on its NMDA receptor platform.
The company holds Fast Track Designation for NRX-100 (intravenous ketamine) for suicidal ideation in depression and Breakthrough Therapy Designation for NRX-101 for suicidal bipolar depression.
In October 2026, the Defense Advanced Research Projects Agency awarded NRx an $11.25 million contract for a phase 3 trial of NRX-101.
A conference call regarding the FDA approval was scheduled for 8:30 a.m. ET on October 30, 2026, with a live webcast available on the company's investor relations website.