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NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Announces Expanded Access Policy for NRX-100 (preservative-free ketamine)
US Food and Drug Administration (FDA) has granted Fast Track designation for NRX-100 in the treatment of suicidal ideation in patients with depression,
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"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 [email protected]. 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 a...