NRx Pharmaceuticals (NASDAQ: NRXP) announced that minutes from a Type C meeting with the U.S. Food and Drug Administration support the agency’s willingness to review a New Drug Application for NRX-100, a preservative-free ketamine formulation, based on existing clinical trial data demonstrating substantial evidence of effectiveness without requiring additional clinical trials. The company said the FDA also confirmed openness to reviewing Real World Evidence as confirmatory data and indicated no additional nonclinical or bridging studies would be required, while NRx plans to pursue a primary indication for treating severe depression in patients who may experience suicidal ideation and continues to await a Summer 2026 decision on a separate Abbreviated New Drug Application for preservative-free ketamine for anesthesia use.
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