FDA Fast Track Designation for NRX-100 for Suicidal Ideation in Patients With Depression, Including Bipolar Depression

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NRx Pharmaceuticals today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to NRX-100 for the treatment of suicidal ideation in patients with depression, including bipolar depression.¹

NRX-100 is the first preservative-free formulation of intravenous ketamine for acute suicidal crises in depression. Currently available forms of ketamine contain the preservative benzethonium chloride, but its safety for repeated use has never been demonstrated.²

This designation for NRX-100 as a standalone drug is a 10-fold expansion of its addressable population, especially when compared with the designation granted in 2017 for NRX-100 in combination with NRX-101 (DCS/lurasidone) for treatment of only acute suicidality in bipolar depression.³

In granting the Fast Track designation, the FDA made the determination that NRX-100 has the potential to address an unmet medical need based on an assessment of the submitted preliminary data. This determination of unmet medical need aligns with the eligibility requirements for the Commissioner's National Priority Voucher Program (CNPV) and for the FDA's Accelerated Approval Program. NRx Pharmaceuticals has applied for a CNPV, which could substantially shorten the review cycle for NRX-100.The newly announced CNPV pathway was introduced by FDA Commissioner Marty Makary, MD, MPH, on June 17, 2025, and is intended to expedite reviews for medications that address US public health priorities. The voucher program allows eligible applications to be reviewed in as little as 1 to 2 months, compared with the standard 10 to 12 months, through a Commissioner-led, team-based approach rather than the traditional system which entails the application being routed and reviewed by various FDA offices.⁴

The Fast Track designation request contained data from several well-controlled trials, all of which demonstrated a clinically meaningful and statistically significant reduction of suicidal ideation. In a Columbia University study, patients with suicidal ideation treated with intravenous ketamine demonstrated a 55% response (ie, 50% reduction in suicidality) compared with a 30% response to active comparator (P<.02). In another trial sponsored by the Government of France, 63% of patients achieved full remission from suicidal ideation in 3 days compared with 31% of those who received placebo (P<.001). This effect has not been shown with intranasal ketamine.

"We thank FDA for its thoughtful review of our Fast Track designation request, and believe this regulatory determination is a significant step forward in our goal to address the national crisis of suicide among soldiers, first responders, veterans, and civilians alike," said Jonathan C. Javitt, MD, MPH, chairman and CEO of NRx Pharmaceuticals. "Large-scale government-supported trials have demonstrated a robust and statistically significant reduction in suicidal ideation and depression with administration of ketamine. This drug was also proven to be noninferior to electroshock therapy in treating depression without the negative [adverse] effects of ECT. We look forward to working closely with the FDA in our quest to Bring Hope to Life."¹

Under the requirements of the Fast Track program, NRx Pharmaceuticals will post an expanded access policy for NRX-100 in the next 2 weeks and seek a meeting with FDA leadership to finalize the data to be submitted under the Accelerated Approval / CNPV application.

NRx concurrently is also preparing a New Drug Application for the treatment of suicidal depression and posttraumatic stress disorder.⁵

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. Goldstein MH, Silva FQ, Blender N, et al. Ocular benzalkonium chloride exposure: problems and solutions. Eye (Lond). 2022;36(2):361-368.

3. 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

4. FDA to issue new commissioner’s national priority vouchers to companies supporting U.S. national interests. Press release. June 17, 2025. Accessed August 11, 2025. https://www.fda.gov/news-events/press-announcements/fda-issue-new-commissioners-national-priority-vouchers-companies-supporting-us-national-interests

5. NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) announces filing of commissioner's national priority voucher application for intravenous ketamine (NRX-100). Press release. June 23, 2025. Accessed August 11, 2025. https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-inc-nasdaqnrxp-announces-filing-of-commissioners-national-priority-voucher-application-for-intravenous-ketamine-nrx-100-302487956.html