NRX Pharma Advances Ketamine Therapy Toward FDA Filing for Severe Depression | NewsOut

Biotech and mental health investors: NRX Pharmaceuticals (NASDAQ: NRXP) has completed a high-level meeting with the U.S. Food and Drug Administration outlining a potential regulatory pathway for filing a New Drug Application for NRX-100, a preservative-free intravenous ketamine therapy.

Reporting from NewsOut, Anna Berry explains the filing could rely on existing clinical trial results plus real-world evidence from more than 65,000 patients treating severe depression with suicidality. The company is also exploring expanded use for treatment-resistant depression, potentially broadening psychiatric care options for high-risk patients.

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