Tuesday, 02 January 2024 12:17 GMT

Biomednewsbreaks - Nrx Pharmaceuticals, Inc. (NASDAQ: NRXP) Receives FDA Approval Of Suitability Petition For Preservative-Free Ketamine Product


(MENAFN- Investor Brand Network) NRx Pharmaceuticals (NASDAQ: NRXP) , a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration has granted its Suitability Petition for KETAFREE(TM), a planned single-patient, preservative-free ketamine product. Unlike current ketamine offerings in multi-dose vials containing the toxic preservative Benzethonium Chloride, KETAFREE(TM) is designed to eliminate such additives. The approval enables immediate re-filing of the Company's Abbreviated New Drug Application. NRx noted the product supports federal priorities of re-shoring sterile drug manufacturing and removing harmful preservatives, with the ketamine market estimated at $750 million. The Company is also advancing NRX-100, a non-generic ketamine formulation under development for suicidal depression and PTSD.

To view the full press release, visit

About NRx Pharmaceuticals, Inc.

NRx Pharmaceuticals, Inc. (), 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

About BioMedWire

BioMedWire (“BMW”) is a specialized communications platform with a focus on the latest developments in the Biotechnology (BioTech), Biomedical Sciences (BioMed) and Life Sciences sectors. It is one of 70+ 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, BMW 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, BMW brings its clients unparalleled recognition and brand awareness.

BMW is where breaking news, insightful content and actionable information converge.

To receive SMS alerts from BioMedWire,“Biotech” to 888-902-4192 (U.S. Mobile Phones Only)

For more information, please visit

Please see full terms of use and disclaimers on the BioMedWire website applicable to all content provided by BMW, wherever published or re-published: /Disclaimer

BioMedWire
Austin, Texas

512.354.7000 Office
[email protected]

BioMedWire is powered by IBN

MENAFN24092025000224011066ID1110106313

Legal Disclaimer:
MENAFN provides the information “as is” without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the provider above.

Search