NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, said the FDA has received its Abbreviated New Drug Application for KETAFREE(TM), a preservative-free intravenous ketamine formulation, deeming the submission “substantially complete” and assigning a July 29, 2026 review goal date. CEO Jonathan Javitt said KETAFREE is designed to provide a single-patient, preservative-free alternative to current multidose ketamine vials that contain Benzethonium Chloride, a compound no longer recognized as safe by the FDA. The Company said KETAFREE aligns with MAHA initiatives to remove toxic substances from medicines and supports domestic supply-chain priorities, with potential 2026 approved drug sales if approved on schedule. NRx noted the program is separate from NRX-100, its Fast Track-designated treatment for suicidal depression, and said it continues to advance its broader pipeline and HOPE Therapeutics clinics.
To view the full press release, visit https://ibn.fm/ODbfj
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 recently filed an Abbreviated New Drug Application (ANDA) and initiated a New Drug Application filing for NRX-100 (IV ketamine) with an application for the Commissioner’s National Priority Voucher Program for the treatment of suicidal depression.
NOTE TO INVESTORS: The latest news and updates relating to NRXP are available in the company’s newsroom at https://ibn.fm/NRXP
About PsychedelicNewsWire
PsychedelicNewsWire (“PNW”) is a specialized communications platform with a focus on all aspects of psychedelics and the latest developments and advances in the psychedelics sector. It is one of 75+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, PNW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today’s market, PNW brings its clients unparalleled recognition and brand awareness. PNW is where breaking news, insightful content and actionable information converge.
To receive SMS alerts from PsychedelicNewsWire, text “Groovy” to 888-902-4192 (U.S. Mobile Phones Only)
For more information, please visit https://www.PsychedelicNewsWire.com
Please see full terms of use and disclaimers on the PsychedelicNewsWire website applicable to all content provided by PNW, wherever published or re-published: https://www.PsychedelicNewsWire.com/Disclaimer
PsychedelicNewsWire
Austin, Texas
www.PsychedelicNewsWire.com
512.354.7000 Office
Editor@PsychedelicNewsWire.com
PsychedelicNewsWire is powered by IBN
