NRx Pharmaceuticals Announces Expanded Access Policy for NRX-100 Following FDA Fast Track Designation for Suicidal Depression Treatment

NRx Pharmaceuticals announced an expanded access policy for NRX-100 following FDA Fast Track designation for treating suicidal ideation in patients with depression. Eligible patients can access the investigational therapy under specific conditions. Chairman and CEO Dr. Jonathan C. Javitt stated the company's commitment to making NRX-100 available to patients with limited options while advancing its clinical development program.

NRx Pharmaceuticals (NASDAQ: NRXP) has announced an expanded access policy for its investigational drug NRX-100 following the U.S. Food and Drug Administration (FDA) Fast Track designation for treating suicidal ideation in patients with depression, including bipolar depression. This move aims to make NRX-100 available to patients who have not responded to other approved treatments and are at high risk of suicide.

The FDA's Fast Track designation reflects the agency's determination that NRX-100 has the potential to address an unmet medical need. The designation was granted based on preliminary data showing significant reductions in suicidal ideation in patients treated with NRX-100 [1].

NRX-100 is a preservative-free intravenous ketamine formulation, making it the first ketamine formulation without preservatives. It targets N-methyl-D-aspartate receptors to quickly decrease suicidal ideation, making it particularly useful in cases of acute suicidal crises requiring immediate treatment [2].

Chairman and CEO Dr. Jonathan C. Javitt stated that the company is committed to making NRX-100 available to patients with suicidal depression who have limited options. He emphasized that the expanded access program will allow physicians to request NRX-100 for eligible patients under specific conditions, including lack of response or tolerance to approved treatments and sufficient supporting clinical data [3].

Physicians interested in acquiring NRX-100 for their patients under the FDA Expanded Access Program can contact NRx Pharmaceuticals directly. For more information, visit the company's website at [NRx Pharmaceuticals Expanded Access Program](https://www.nrxpharma.com/expandedaccess/nrx-100) or write to expandedaccess@nrxpharma.com.

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]