NRx Pharmaceuticals advances ketamine application after FDA review

NRx Pharmaceuticals Inc. has advanced its application for a preservative-free ketamine treatment following an initial review by the Food and Drug Administration (FDA). The FDA reported no major deficiencies regarding the drug or its manufacturing, though a packaging-related matter remains under review. The company has submitted requested documentation regarding the manufacturing of the vial’s syringe-connection component.

NRx is preparing for a potential 2026 launch and has begun producing 5 million doses for inventory. Separately, the company is seeking approval for NRX-100, an intravenous treatment for depression, with a target decision date in 2027. Additionally, NRx has been selected as the prime contractor for a federally backed trial involving NRX-101 and robotic transcranial magnetic stimulation for treatment-resistant depression, with anticipated funding from the Defense Advanced Research Projects Agency exceeding $11.5 million.