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NRx Pharmaceuticals (NASDAQ: NRXP) Receives FDA Fast Track Designation for NRX-100 in Treating Suicidal Ideation in Depression
LOS ANGELES, CA - August 14, 2025 (NEWMEDIAWIRE) - NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to NRX-100 for treating suicid...
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"LOS ANGELES, CA - August 14, 2025 (NEWMEDIAWIRE) - NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to NRX-100 for treating suicidal ideation in patients with depression, including bipolar depression - a 10-fold expansion from its prior 2017 designation for use with NRX-101 in suicidal bipolar depression. The FDA's determination, based on preliminary data, also supports potential eligibility for the Commissioner's National Priority Voucher Program and the Accelerated Approval Program. Controlled trials licensed by NRx showed NRX-100 (IV ketamine) reduced suicidal ideation significantly, with one Columbia University study reporting a 55% response rate versus 30% for active comparator (P<.02) and a French government-sponsored trial showing 63% remission in three days versus 31% with placebo (P<.001). NRx plans to post an expanded access policy within two weeks and meet with FDA leadership to finalize data for submission under the Accelerated Approval/CNPV pathway.","length":1120,"tagName":"p"},{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":"Investor Brand Network","className":"","disableSlideshowImg":false,"size":{"original":{"width":610,"height":520,"url":"https://media.zenfs.com/en/newsmediawire_165/d8af5ae9288c0f70ceb08aa9713a28cf"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/kpD0NvVnaK_aNpdu.cQQ2w--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTgxODtjZj13ZWJw/https://media.zenfs.com/en/newsmediawire_165/d8af5ae9288c0f70ceb08aa9713a28cf","width":610,"height":520}}},{"type":"text","content":"To view the full press release, visit https://ibn.fm/n7epy","length":58,"tagName":"p"},{"type":"text","content":"About NRx Pharmaceuticals, Inc.","length":31,"tagName":"p"},{"type":"text","content":"NRx Pharmaceuticals 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...