NEW YORK, NY / ACCESS Newswire / August 11, 2025 / New to The Street proudly spotlights its esteemed client, NRx Pharmaceuticals, Inc. (NASDAQ:NRXP), which today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NRX-100 in the treatment of suicidal ideation in patients with depression, including bipolar depression.
This designation represents a 10-fold expansion in the potential patient population compared to the FDA's 2017 Fast Track designation for bipolar depression alone - now encompassing the 13 million U.S. adults who consider suicide each year. The FDA's decision also recognizes NRX-100's potential to address an unmet medical need, qualifying it for eligibility under the Commissioner's National Priority Voucher Program (CNPV) and accelerated approval pathways.
Supported by multiple large-scale, well-controlled trials - including pivotal studies from Columbia University and the Government of France - NRX-100 (preservative-free IV ketamine) demonstrated rapid and statistically significant reductions in suicidal ideation, in some cases doubling remission rates compared to placebo.
"We thank the FDA for its thoughtful review of our Fast Track designation request," said Dr. Jonathan Javitt, Chairman & CEO of NRx Pharmaceuticals. "This recognition is a major step toward addressing the national crisis of suicide affecting civilians, soldiers, veterans, and first responders. We are committed to working closely with the FDA to bring this life-saving therapy to those who need it most."
"At New to The Street, we are honored to help share NRx Pharmaceuticals' groundbreaking achievements with millions of viewers across our national television platforms," said Vince Caruso, Co-Founder & CEO of New to The Street. "FDA Fast Track designation is not just a regulatory milestone - it's a pivotal moment in the fight against one of our nation's most urgent public health crises, and we're proud to help amplify this story."
A First-in-Class Formulation
NRX-100's preservative-free formulation offers a key safety advantage by eliminating benzethonium chloride - a toxic preservative found in some ketamine products - and is manufactured in the U.S. with a three-year room-temperature shelf life. The Company has initiated U.S. high-volume manufacturing and filed a Citizen Petition to remove benzethonium chloride from all IV ketamine products.
Next Steps Under Fast Track
Under the program, NRx will seek Accelerated Approval and Priority Review, post an expanded access policy within two weeks, and engage FDA leadership to finalize its data package for review. The Company's goal is to expand access to this potentially life-saving treatment to all Americans, beyond those currently able to pay out-of-pocket.
With the U.S. suicidal depression market estimated at over $3 billion annually, this milestone has both profound societal impact and significant commercial potential.
About NRx Pharmaceuticals, Inc.
NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) is a clinical-stage biopharmaceutical company developing breakthrough therapeutics based on its NMDA platform to address serious central nervous system disorders, including suicidal depression, chronic pain, and PTSD. The Company's lead candidates include NRX-100, a preservative-free intravenous ketamine formulation awarded Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of suicidal ideation in depression, including bipolar depression, and NRX-101, an oral fixed-dose combination of D-cycloserine and lurasidone, awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression.
NRx has recently filed both an Abbreviated New Drug Application (ANDA) and initiated a New Drug Application (NDA) for NRX-100, alongside an application for the Commissioner's National Priority Voucher Program. These filings are supported by data from well-controlled clinical trials conducted under the auspices of the U.S. National Institutes of Health and the Government of France, licensed to NRx under a formal data-sharing agreement.
For more information, please visit www.nrxpharma.com.
About New to The Street
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SOURCE: New To The Street
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