NetworkNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Applies for FDA Commissioner’s Priority Voucher for NRX-100 Ketamine Formulation
NRx Pharmaceuticals (NASDAQ: NRXP) has filed for the newly launched FDA Commissioner’s National Priority Voucher (CNPV) program, seeking accelerated review for NRX-100, its preservative-free intravenous ketamine formulation. The company believes NRX-100 meets all criteria outlined by FDA Commissioner Marty Makary, who announced the voucher program on June 17, 2025, to prioritize treatments aligned with urgent U.S. health needs—including suicidal depression and PTSD.
NRx has already submitted the chemistry, manufacturing, and controls (CMC) portion of its application and received FDA feedback, placing it on track for potential accelerated review of its full New Drug Application (NDA) by late 2025. If granted, the voucher would cut review times to 1–2 months versus the standard 10–12 months. Concurrently, NRx is advancing a citizen petition to withdraw preservative-containing ketamine products and has filed a patent for its preservative-free manufacturing process, aiming to capture share in a ketamine market projected to reach up to $5 billion annually by 2033.
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain, and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently initiated a New Drug Application filing for NRX-100 (IV ketamine) for the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
NOTE TO INVESTORS: The latest news and updates relating to NRXP are available in the company’s newsroom at https://nnw.fm/NRXP
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
NRx Pharmaceuticals (NASDAQ: NRXP) has filed for the newly launched FDA Commissioner’s National Priority Voucher (CNPV) program, seeking accelerated review for NRX-100, its preservative-free intravenous ketamine formulation. The company believes NRX-100 meets all criteria outlined by FDA Commissioner Marty Makary, who announced the voucher program on June 17, 2025, to prioritize treatments aligned with urgent U.S. health needs—including suicidal depression and PTSD.
NRx has already submitted the chemistry, manufacturing, and controls (CMC) portion of its application and received FDA feedback, placing it on track for potential accelerated review of its full New Drug Application (NDA) by late 2025. If granted, the voucher would cut review times to 1–2 months versus the standard 10–12 months. Concurrently, NRx is advancing a citizen petition to withdraw preservative-containing ketamine products and has filed a patent for its preservative-free manufacturing process, aiming to capture share in a ketamine market projected to reach up to $5 billion annually by 2033.
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain, and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently initiated a New Drug Application filing for NRX-100 (IV ketamine) for the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
NOTE TO INVESTORS: The latest news and updates relating to NRXP are available in the company’s newsroom at https://nnw.fm/NRXP
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
