NRx Pharmaceuticals Expands Access to NRX-100 for Suicidal Ideation Treatment

NRx Pharmaceuticals has announced an expanded access policy for NRX-100 based on the FDA's Fast Track designation for the treatment of suicidal ideation in patients with depression, including bipolar depression. The FDA has determined that NRX-100 has the potential to address an unmet need, making it available for expanded access to eligible patients.

NRx Pharmaceuticals (NASDAQ: NRXP) has announced an expanded access policy for NRX-100, a preservative-free ketamine, to treat suicidal ideation in patients with depression, including bipolar depression. The decision follows the FDA's Fast Track designation, which highlights NRX-100's potential to address unmet clinical needs and significant efficacy in reducing suicidality [1].

The FDA's Fast Track designation recognizes NRX-100 as a standalone drug, broadening its addressable patient population, particularly for acute suicidal crises. The drug targets N-methyl-D-aspartate (NMDA) receptors to more quickly decrease suicidal ideation, with studies showing a 55% response rate compared to a 30% response to an active comparator [2]. This distinguishes intravenous ketamine administration as a potentially more effective form of treatment.

NRX-100 is now available upon physician request for patients meeting the expanded access criteria, which include life-threatening conditions unresponsive to other treatments. Physicians must ensure patients meet these criteria to qualify for the expanded access program [3].

The company's CEO, Jonathan C. Javit, MD, expressed the urgency to make NRX-100 available to patients with suicidal depression where approved therapies are not tolerated or effective. The expanded access program aims to serve patients in need, with clinicians able to request NRX-100 by contacting expandedaccess@nrxpharma.com or visiting the company's website [4].

NRx Pharmaceuticals has also made strategic advancements in its drug development pipeline, including three drug approval applications in progress. Despite facing liquidity concerns with only $2.9 million in cash and cash equivalents as of June 30, 2025, the company has reduced its quarterly operating loss by approximately 50% year-over-year [5].

The company's dual commercial strategy aims to target both generic and branded markets for NRX-100. It has filed an Abbreviated New Drug Application (ANDA) for NRX-100 to enter the $750 million generic ketamine market in early 2026, while simultaneously pursuing accelerated approval as a novel, branded therapy for suicidal depression [5].

NRx Pharmaceuticals faces regulatory uncertainties, particularly regarding the FDA's response to a citizen petition to remove benzethonium chloride from ketamine formulations, which could impact NRX-100's market potential [5]. However, the company's strategic vision for commercialization and integration through HOPE Therapeutics offers a comprehensive care model for patients with suicidal depression and PTSD.

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](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](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](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](https://www.fda.gov/news-events/public-health-focus/expanded-access)
[5] NRX Pharmaceuticals Inc. (NASDAQ:NRXP) reported its Q2 2025 financial results, showing mixed signals of progress and challenges. [https://sg.finance.yahoo.com/news/nrx-pharmaceuticals-inc-nrxp-q2-070528598.html](https://sg.finance.yahoo.com/news/nrx-pharmaceuticals-inc-nrxp-q2-070528598.html)