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.
To view the full press release, visit https://ibn.fm/QBhWd
About NRx Pharmaceuticals, Inc.
NRx Pharmaceuticals, Inc. (www.nrxpharma.com) is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The Company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101 (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx has filed an Abbreviated New Drug Application (ANDA), and initiated a New Drug Application filing for NRX-100 with an application for the Commissioner’s National Priority Voucher Program for the treatment of suicidal ideation in patients with depression, including bipolar depression.
NOTE TO INVESTORS: The latest news and updates relating to NRXP are available in the company’s newsroom at https://ibn.fm/NRXP
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