FDA meeting points to NRX-100 NDA supported by clinical and real-world ketamine data

NRx Pharmaceuticals said it completed an in-person Type C guidance meeting with the FDA on February 17 that indicated a path to filing a New Drug Application for NRX-100 (preservative-free ketamine) based on existing clinical trial data and real-world evidence from more than 65,000 patients. The company said it will seek a broader indication to serve patients with treatment-resistant depression who may have suicidality, rather than only the subset with suicidality. NRx said the application would be pursued under Fast Track Designation.

Based on oral guidance received at the meeting, NRx said it has a path to filing an application for new drug approval of NRX-100 based on substantial evidence of effectiveness derived from existing data from adequate and well controlled trials together with confirmatory evidence from the real-world evidence dataset. The meeting was attended by leaders of the FDA Division of Psychiatry Products, the FDA Office of Neuroscience, and the FDA Center for Drug Evaluation and Research.

The company said it plans to submit data on the real-world use of ketamine in over 70,000 patients in support of the accelerated approval of NRX-100. Preliminary analyses suggested the clinical response to intravenous ketamine is consistent with prior randomized trial data and compares favorably to currently-approved products.

NRx said it and the FDA will work collaboratively in the coming weeks to finalize the statistical analysis protocol for the full 65,000-person real-world evidence dataset under newly published FDA guidance. In preliminary comments ahead of the meeting, FDA advised the company that no additional nonclinical data would be required for review of the New Drug Application and that no bridging studies would be needed to support the preservative-free formulation compared with the currently approved preservative-containing formulation of ketamine.

Separately, NRx said it received a letter from the FDA Office of Generic Drugs indicating preliminary alignment on labeling for its preservative-free ketamine product, following a previous preliminary determination of bioequivalence. The company said the product is still subject to final review and that it anticipates a decision under the Generic Drug User Fee Act in Summer 2026. NRx said the product has the potential to substantially enhance the supply of U.S.-manufactured ketamine while several suppliers are on backorder.