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NRx Pharmaceuticals (Nasdaq:NRXP) Confirms Path to New Drug Application with Real World Data and Broader Proposed Indication for NRX-100 (ketamine) Following Type C FDA Meeting
NRx has received confirmatory FDA minutes from in-person Type C meeting attended by leadership of FDA Division of Psychiatry, FDA Office of Neuroscience, and
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"NRx has received confirmatory FDA minutes from in-person Type C meeting attended by leadership of FDA Division of Psychiatry, FDA Office of Neuroscience, and FDA Center for Drug Evaluation and Research.Minutes are consistent with previously announced oral guidance outlining a path to New Drug Approval of NRX-100 for a broadened indication of treating depression, including patients with suicidality.FDA confirmed willingness to review existing Adequate and Well Controlled Clinical Trial data as Substantial Evidence of Efficacy together with Real World Evidence from Osmind, Inc. as confirmatory evidence of efficacy.No additional clinical trials were requested.Company intends to sumbit its New Drug Application for NRX-100 by June 2026. WILMINGTON, Del., March 16, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, today announced that it has received confirmatory minutes from an in-person Type C guidance meeting at the headquarters of the US Food and Drug Administration. 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 minutes support FDA’s willingness to review NRx’s application for New Drug Approval of NRX-100 (preservative-free ketamine) based on Substantial Evidence of Effectiveness derived from existing adequate and well controlled trials. No additional clinical trials were requested. NRx agreed with FDA to submit existing patient-level data for review. In the trials discussed with FDA, ketamine has demonstrated dramatic superiority to placebo and to active placebo, together with non-inferiority versus electroshock therapy. Moreover, ketamine has demonstrated statistically significant reduction in suicidal ideation. Notably, electroshock therapy, the only currently-approved treatment for suicidal ideation demonstrated a 30% incidence of memory loss, whereas ketamine did not. The FDA minutes additionally confirm FDA’s willingness to review Real World Evidence as confirmatory evidence of efficacy. Preliminary analysis of that Real World Evidence confirms the effectiveness of intravenous ketamine both in reducing depression and suicidal ideation. Based on the meeting minutes, NRx will seek a primary indication to treat depression in patients with severe d...