NRx Pharmaceuticals (Nasdaq:NRXP) Welcomes Presidential Initiative to Accelerate Approval of Psychedelic Medications to Treat Depression, PTSD, and Suicidality
- President Trump signed an Executive Order: ACCELERATING MEDICAL TREATMENTS FOR SERIOUS MENTAL ILLNESS on April 18, 2026.
- The order directs acceleration of research and lowered barriers to approvals of psychedelic medications to treat depression, PTSD, and suicidality.
- NRx Pharmaceuticals has been awarded Fast Track designation and recently received FDA guidance anticipating NRx's upcoming New Drug Application for NRX-100 (preservative free ketamine) to treat depression, including bipolar depression, in patients who may have suicidal ideation.
- Suicide remains the second leading cause of death among Americans under the age of 35 and the only currently-approved treatment for suicidality in depression remains Electroshock Therapy.
WILMINGTON, Del., April 20, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals (NASDAQ:NRXP) welcomes the newly-signed Executive Order: ACCELERATING MEDICAL TREATMENTS FOR SERIOUS MENTAL ILLNESS, signed by President Trump on April 18, 2026. In the Order, the President notes that, "It is the policy of my Administration to accelerate innovative research models and appropriate drug approvals to increase access to psychedelic drugs that could save lives and reverse the crisis of serious mental illness in America."
"We thank President Trump, Secretary Kennedy, and Commissioner Makary for their leadership and decisive action to address America's mental health crisis, particularly the devastating toll of PTSD and suicide among our veterans," said Jonathan C. Javitt, MD, MPH, Chairman and CEO of NRx Pharmaceuticals. "The Administration has lent Presidential authority to a commitment to act with urgency on behalf of patients and families who can no longer wait. NRx shares that mission and is proud to be aligned with this Administration in advancing solutions for severe depression, PTSD, and the mental health of military personnel, veterans, and first responders."
The order directs the Commissioner of the US Food and Drug Administration to provide Commissioner's National Priority Vouchers (CNPV) to appropriate psychedelic drugs that have received a Breakthrough Therapy designation and are in accordance with the criteria of the National Priority Voucher Program. NRx has applied for a CNPV in support of its upcoming New Drug Application for NRX-100.
The Presidential order further directs the Department of Health and Human Services and FDA to collaborate with the Department of Veterans Affairs and the Private Sector to increase clinical trial participation, data sharing, and real-world evidence generation regarding psychedelic drugs …to facilitate the timely evaluation and approval of drugs that meet standards for approval under section 505 of the Federal Food, Drug, and Cosmetic Act. This aspect of the executive order is expected to facilitate NRx's proposed use of Real World Evidence and already-completed federally-funded clinical trials in support of drug approval. The order is consistent with recently-announced guidance from an FDA Type C meeting lead by the Deputy Director of the FDA Center for Drug Evaluation and Research and the Director of the FDA Division of Psychiatry Products.
"FDA's supportive guidance on the use of existing clinical trials and Real World Evidence has now been amplified by a Presidential Executive Order," continued Dr. Javitt. "This bold and practical leadership by the Administration will save lives that are needlessly lost to depression and suicidality. The neuroplastic drugs anticipated by this order, combined with treatments such as Transcranial Magnetic Stimulation and Hyperbaric Oxygen Therapy are demonstrating remarkable and revolutionary results in clinical trials and early clinical initiatives. We are anticipating an era in which severe depression, PTSD, and suicidality may be as treatable and repairable as physical trauma."
About NRx Pharmaceuticals, Inc.
NRx Pharmaceuticals, Inc. (www.nrxpharma.com), is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The Company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx has filed an Abbreviated New Drug Application (ANDA), and initiated a New Drug Application filing for NRX-100 for the treatment of suicidal ideation in patients with depression, including bipolar depression.
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For further information:
Brian Korb
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(917) 653-5122
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