New Expanded Access Policy for NRX-100 for Suicidal Ideation

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NRx Pharmaceuticals announced expanded access for NRX-100, a preservative free intravenous ketamine, in treating suicidal ideation in patients with depression following the Fast Track designation by the US Food and Drug Administration (FDA).¹ NRX-100 is available upon physician request for patients meeting the expanded access criteria.

NRX-100 is intended to treat suicidal ideation and acute suicidal crises in patients suffering from depression, specifically including those with bipolar depression. The drug is the first ketamine formulation without preservatives; most forms of available ketamine contain benzethonium chloride as a preservative, which has not been evaluated for safety in repeated use.

With the FDA’s grant of Fast Track designation, NRX-100 was determined to have potential to address an unmet clinical need. This assessment was based on information from the Fast Track designation request, containing data from multiple trials showing statistically significant reductions in suicidal ideation in patients.² A study from Columbia University showed patients with suicidal ideation who received intravenous ketamine demonstrated a 55% response (ie, 50% reduction in suicidality) compared with a 30% response to an active comparator (P<.02). These results have not been seen in previous intranasal ketamine studies, distinguishing IV ketamine administration as a potentially more effective form.³

Because of the short-lived effects of ketamine treatments, drugs like NRX-100 are useful in cases of acute suicidal crisis requiring immediate treatment. NRX-100 targets N-methyl-D-aspartate receptors to more quickly decrease suicidal ideation. With the FDA recognition of NRX-100 as a standalone drug, the addressable population has increased significantly from previous FDA approval of NRX-100 in combination with NRX-101 for treatment of suicidal bipolar depression.³

Physicians should be aware of the FDA criteria their patients must meet in order to qualify for the expanded access program. The patient must present with a life-threatening illness or condition which is no longer responsive to other approved treatment options and a benefit-risk analysis must be conducted, taking into account the physician’s assessment of the patient’s history and condition.⁴

Jonathan C Javit, MD, chairman and CEO of NRx Pharmaceuticals, said in a press release, “We at NRx recognize the urgent need to make NRX-100 available to patients with suicidal depression for whom approved therapies are not tolerated or effective. We look forward to participating in FDA’s expanded access program and to serving patients in need.”

Clinicians interested in acquiring NRX-100 for their patients under the FDA Expanded Access Program should write to expandedaccess@nrxpharma.com or visit the company’s website at https://www.nrxpharma.com/expandedaccess/nrx-100. For more information on expanded access medications generally, physicians and patients can see the Reagan-Udall foundation website, which provides further public education.

References

1. NRx Pharmaceuticals, Inc. announces expanded access policy for NRX-100 (preservative-free ketamine). NRx Pharmaceuticals. Press release. August 27, 2025. Accessed August 27, 2025. https://www.globenewswire.com/news-release/2025/08/27/3139980/0/en/NRx-Pharmaceuticals-Inc-NASDAQ-NRXP-Announces-Expanded-Access-Policy-for-NRX-100-preservative-free-ketamine.html

2. Kuntz L. FDA grants Fast Track designation for NRX-100 for suicidal ideation in patients with depression, including bipolar depression. Psychiatric Times. August 11, 2025. https://www.psychiatrictimes.com/view/fda-fast-track-designation-for-nrx-100-for-suicidal-ideation-in-patients-with-depression-including-bipolar-depression

3. NRx Pharmaceuticals, Inc. granted FDA Fast Track designation for NRX-100 for suicidal ideation in patients with depression, including bipolar depression. NRx Pharmaceuticals. August 11, 2025. Accessed August 27, 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

4. Expanded access. US Food and Drug Administration. February 28, 2024. Accessed August 27, 2025. https://www.fda.gov/news-events/public-health-focus/expanded-access