FDA Grants Fast Track To NRx's NRX-100 For Suicidal Depression; Expanded Access Now Available For Eligible Patients

Author: Benzinga Newsdesk | August 27, 2025 08:10am

• US Food and Drug Administration (FDA) has granted Fast Track designation for NRX-100 in the treatment of suicidal ideation in patients with depression, including bipolar depression.
• NRx Pharmaceuticals is making NRX-100 available on an expanded access basis upon physician request for patients with serious or life-threatening suicidal depression despite treatment with currently available therapy.
• Approximately 13 million adults seriously consider suicide each year, according to the CDC. An American dies from suicide every 11 minutes.
• Physicians may apply for expanded access on behalf of patients who meet expanded access criteria by writing to expandedaccess@nrxpharma.com. Further information may be viewed at https://www.nrxpharma.com/expandedaccess/nrx-100.

WILMINGTON, Del., Aug. 27, 2025 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (NASDAQ:NRXP), a clinical-stage biopharmaceutical company, today announced its expanded access policy for NRX-100 (preservative-free ketamine) based on grant of Fast Track designation for NRX-100 in the treatment of suicidal ideation in patients with depression, including bipolar depression.

In granting the Fast Track designation, FDA made the determination that NRX-100 has the potential to address an unmet need, based on an assessment of the preliminary data contained in the Fast Track designation request. Accordingly, NRX-100 is available for expanded access to eligible patients. More about this program can be learned from the Reagan Udall Foundation, https://navigator.reaganudall.org/, which works in conjunction with the FDA to provide public information on expanded access medications.

Upon physician request, NRx Pharmaceuticals may make NRX-100 available to patients when certain conditions, including the following are met:

• The patient has a serious or life-threatening illness or condition and is either no longer responsive to or not able to tolerate any approved treatment option;
• The investigational drug is in active clinical development with sufficient data available to determine an appropriate dose and schedule for the patient's specific condition;
• A benefit-risk analysis, based on both the available clinical data as well as the requesting physician's assessment of the individual patient's condition and history, supports making the investigational drug available;
• Making the investigational drug available will not negatively impact or delay the conduct of clinical trials or regulatory review or approval of the investigational drug for broader patient access; and
• Adequate supply of the investigational drug is available.

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