FDA Grants NRX-100 Fast Track Designation for Suicidal Ideation

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, according to an announcement from NRx Pharmaceuticals on August 11, 2025.1

“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 Javitt, chairman and CEO of NRx Pharmaceuticals, in a statement.1

The Centers for Disease Control and Prevention (CDC) reported that approximately 13 million adults contemplate suicide each year, with 1.5 million attempts. Someone from the US dies from suicide every 11 minutes. NRX-100, an IV ketamine for suicidality in patients with depression, addresses the national suicide crisis.

NRX-100 is the first preservative-free intravenous ketamine to be filed with the FDA. The same morning as this announcement, PharmaTher announced the FDA approval of ketamine (KetaRx) for surgical pain management, opening the door for advancing ketamine development in other areas, including mental health.2

Previously, the FDA Fast Track Designation granted in 2017 had been for NRX-100 in combination with NRX-101 (DCS/lurasidone) for the treatment of suicidal bipolar depression.1 This new designation is for standalone NRX-101 treatment in patients with depression, not exclusively bipolar depression, experiencing suicidal ideation.

The designation was based on large-scale clinical trials demonstrating a clinically meaningful and statistically significant reduction of suicidal ideation. In a Columbia study, suicidal patients treated with intravenous ketamine had a 55% response, compared with a 30% response in the active comparator arm (P < .02). In a study 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).1

NRx Pharmaceuticals plans on posting an expanded excess policy for NRX-100 in the next 2 weeks and securing a meeting with the FDA to finalize the data for their Accelerated Approval/CNPV application. Their results show NRX-100 is superior to both the placebo and active comparator.

“This drug was also proven to be non-inferior to electroshock therapy in treating depression without the negative side effects of ECT,” Javitt added. “We look forward to working closely with the FDA in our quest to Bring Hope to Life."1

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. PR Newswire. August 11, 2025. Accessed 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. Derman, C. FDA Approves PharmaTher’s Ketamine for Surgical Pain Management. HCPLive. August 11, 2025. Accessed August 11, 2025. https://www.hcplive.com/view/fda-approves-pharmather-s-ketamine-for-surgical-pain-management.