NRX Pharmaceuticals Granted FDA Fast Track Designation for NRX-100.

NRx Pharmaceuticals has been granted FDA Fast Track Designation for NRX-100 for suicidal ideation in patients with depression, including bipolar depression. This expands the addressable population to 13 million Americans who consider suicide each year, a 10x increase from the 2017 designation for bipolar depression alone. The FDA has also determined that NRX-100 has the potential to address an unmet need, making it eligible for a Commissioner's National Priority Voucher program.

NRx Pharmaceuticals has received a significant regulatory milestone with the FDA Fast Track designation for NRX-100, its intravenous ketamine treatment for suicidal ideation in patients with depression, including bipolar depression. This expanded designation represents a 10-fold increase in the addressable population compared to its 2017 designation, targeting approximately 13 million Americans who consider suicide annually.

The FDA's determination that NRX-100 addresses an unmet medical need is particularly significant. This designation aligns with the eligibility requirements for the Commissioner's National Priority Voucher (CNPV) program and the FDA's Accelerated Approval Program. The CNPV program can substantially shorten the review cycle for NRX-100, potentially expediting its approval.

Clinical trials demonstrated NRX-100's efficacy, with a 55% response rate in suicidal patients compared to a 30% response to active comparator. In another trial, 63% of patients achieved full remission from suicidal ideation within three days compared to 31% with placebo. These results were not shown with intranasal ketamine, highlighting NRX-100's unique advantages.

NRX-100 is the first preservative-free ketamine formulation filed with the FDA, offering potential three-year room temperature shelf life. This differentiates it from existing ketamine products that contain Benzethonium Chloride, which has safety concerns for repeated use.

NRx Pharmaceuticals is preparing a New Drug Application for NRX-100 to treat suicidal depression and posttraumatic stress disorder (PTSD). The company has completed the CMC information filing and is pursuing a Commissioner's National Priority Voucher to expedite the review process.

The Fast Track designation for NRX-100 significantly expands the market opportunity and accelerates the regulatory pathway for NRx's suicide treatment. This designation represents a substantial regulatory milestone with several key implications, including the potential for a breakthrough therapy addressing a critical public health crisis.

References:
[1] NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) granted FDA Fast Track Designation for NRX-100 for suicidal ideation in patients with depression, including bipolar depression. News release. August 11, 2025. https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-inc-nasdaqnrxp-granted-fda-fast-track-designation-for-nrx-100-for-suicidal-ideation-in-patients-with-depression-including-bipolar-depression-302526237.html
[2] NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) files initial section of U.S. New Drug Application to the FDA for NRX-100 (IV ketamine) for the treatment of suicidal depression. News release. December 30, 2024. https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-inc-nasdaqnrxp-files-initial-section-of-us-new-drug-application-to-the-fda-for-nrx-100-iv-ketamine-for-the-treatment-of-suicidal-depression-302340035.html