NRx says FDA outlined path for NRX-100 depression drug application
NRx said the FDA outlined a path for a New Drug Application for NRX-100, a preservative-free ketamine formulation for depression with suicidality. The company plans to submit the NDA by June 2026 and said no additional nonclinical or bridging studies would be required.
NRx Pharmaceuticals said it completed an in-person Type C guidance meeting with the U.S. Food and Drug Administration and believes it has a path to file a New Drug Application for NRX-100, a preservative-free ketamine formulation. The company said the filing would be supported by existing adequate and well-controlled trials and confirmatory evidence from more than 65,000 patients in a Real World Evidence dataset, and it plans to submit a New Drug Application by June 2026.
The FDA was willing to review existing clinical trial data as substantial evidence, and the company said Real World Evidence from Osmind will serve as confirmatory evidence. Based on oral guidance, NRx said it is also seeking a broader indication for treatment-resistant depression with suicidality.
Ketamine demonstrated superiority to placebo and non-inferiority versus electroshock therapy, according to the materials. The drug also showed statistically significant reduction in suicidal ideation without memory loss.
The FDA advised that no additional nonclinical or bridging studies would be required, and the company said it will work with the agency to finalize a statistical analysis protocol, with further details to follow upon receipt of formal meeting minutes.
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 filed as an Abbreviated New Drug Application. The FDA's comments were limited to minor formatting changes to the proposed label, and the company expects to submit the final label this month.
That determination remains preliminary until final supervisory review of NRx's Abbreviated New Drug Application, with anticipated approval in summer 2026 under the Generic Drug User Fee Act. NRx previously received a preliminary determination of bioequivalence for this product.
The company said the preservative-free ketamine is manufactured in the United States at a time when multiple ketamine suppliers have advised the medical community they are on backorder. NRx said NRX-100 has been awarded Fast Track Designation for the treatment of suicidal ideation in depression, including bipolar depression, and that it has initiated a New Drug Application filing for NRX-100 with an application for the Commissioner’s National Priority Voucher Program.