NRx Pharmaceuticals (NASDAQ: NRXP) announced it has licensed regulatory-grade real-world evidence drawn from more than 70,000 U.S. patients treated with intravenous ketamine or nasal S-ketamine for depression and suicidal ideation to support its application for Accelerated Approval of NRX-100, a preservative-free ketamine, under Fast Track Designation. The dataset, provided by Osmind, includes nearly one million treatment sessions and extensive longitudinal safety and effectiveness data and will be submitted to the U.S. Food and Drug Administration following a 2025 policy update allowing de-identified real-world evidence. NRx is seeking approval of NRX-100 for the treatment of suicidal ideation in depression, including bipolar depression, an area where no drug therapy is currently approved, with the company citing growing off-label use of ketamine and the potential to expand access to supervised treatment through regulatory approval.
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