IV Ketamine NRX-100 Gains FDA Fast Track for Suicidal Depression

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The FDA granted Fast Track designation to NRX-100 (intravenous, preservative-free ketamine) for the treatment of suicidal ideation in patients with depression, including bipolar depression, according to an August 11 announcement from NRx Pharmaceuticals.¹

The designation expands the potential treatment population from suicidal bipolar depression, covered under a 2017 Fast Track decision for NRX-100 in combination with NRX-101, to an estimated 13 million US adults who seriously consider suicide each year, a 10-fold increase, the company said.¹

Based on the agency’s review of preliminary data submitted by NRx Pharmaceuticals in the original Fast Track request, the FDA assessed that the investigational intravenous ketamine formulation has the potential to address an important unmet medical need. The FDA's assessment aligns with eligibility requirements for the Commissioner’s National Priority Voucher (CNPV) program and the agency’s Accelerated Approval pathway. NRx has applied for a CNPV, which could further review timelines, according to the statement.

How effective is NRX-100?

Multiple well-controlled trials supported the CNPV application, NRx said, including¹:

• Columbia University study: Among suicidal participants who received NRX-100, investigators reported a 55% response rate, defined as a 50% or greater reduction in suicidality, vs a rate of 30% with active comparator (P <.02).
• French government–sponsored study: 63% of participants in the active treatment group achieved "full remission" from suicidal ideation within 3 days, compared with 31% who received placebo (P <.001). These effects have not been demonstrated with intranasal ketamine, according to the NRx Pharmaceuticals statement.

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“Large-scale government-supported trials have demonstrated a robust and statistically significant reduction in suicidal ideation and depression with administration of ketamine," Jonathan Javitt, chairman and CEO of NRx Pharmaceuticals, said in the company statement. “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.”¹

NRX-100 has also been shown to be noninferior to electroshock therapy (ECT) for treatment of depressions, and without the negative adverse effects of ECT, Javitt added.¹

According to the CDC, approximately 13 million adults seriously consider suicide each year, 3.7 million make a plan, and 1.5 million attempt suicide.¹ In 2023, 49,316 Americans died from suicide, approximately 1 death every 11 minutes, making it a leading cause of death among individuals aged 10 to 64 and the second leading cause among those aged 10 to 34. Active-duty personnel, veterans, and first responders face a 4-fold higher suicide risk. Suicide rates in the US increased by approximately 36% between 2000 and 2022.²

The Department of Veterans Affairs and Department of Defense currently reimburse IV ketamine for beneficiaries; however, it remains FDA-approved only as an anesthetic and is not reimbursed for suicidality or depression by most insurers.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.¹

NRx concurrently is also preparing a New Drug Application for the treatment of suicidal depression and posttraumatic stress disorder.³

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. NRx Pharmaceuticals. 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. Facts About Suicide. News release. CDC. March 26, 2025. Accessed August 11, 2025. https://www.cdc.gov/suicide/facts/index.html

3. NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) announces filing of commissioner's national priority voucher application for intravenous ketamine (NRX-100). News release. NRX Pharmaceuticals. 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