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Posted On: 08/11/2025 4:57:03 PM
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NetworkNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Receives FDA Fast Track Designation for NRX-100 in Treating Suicidal Ideation in Depression
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.
NOTE TO INVESTORS: The latest news and updates relating to NRXP are available in the company’s newsroom at https://nnw.fm/NRXP
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
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.
NOTE TO INVESTORS: The latest news and updates relating to NRXP are available in the company’s newsroom at https://nnw.fm/NRXP
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
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