- The company has refiled its Abbreviated New Drug Application (“ANDA”) for KETAFREE(TM), a preservative-free IV ketamine formulation.
- The filing follows FDA approval of the company’s Suitability Petition to remove benzethonium chloride (“BZT”), a preservative linked to neurotoxicity.
- In parallel, NRx is advancing NRX-100, another preservative-free ketamine formulation under a New Drug Application (“NDA”) for suicidal ideation in depression, including bipolar depression.
- NRX-100 holds Fast Track Designation and may qualify for the FDA’s National Priority Voucher Program.
- The company also continues work on NRX-101, a Breakthrough Therapy for suicidal bipolar depression.
- CEO Dr. Jonathan Javitt recently discussed new pipeline developments and veteran-focused clinical collaborations during the Noble Capital Markets Emerging Growth Virtual Equity Conference.
NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, is advancing a two-pronged approach to bring preservative-free ketamine-based therapies to market, pursuing distinct regulatory and commercial pathways for both KETAFREE(TM) and NRX-100. (https://ibn.fm/BYg97). The company recently refiled an Abbreviated New Drug Application (“ANDA”) for KETAFREE(TM), a preservative-free intravenous (“IV”) ketamine formulation intended for all currently approved ketamine indications.
This filing follows the U.S. Food and Drug Administration’s approval of NRx’s Suitability Petition to eliminate benzethonium chloride (“BZT”), a chemical preservative still found in many ketamine formulations. BZT, a quaternary ammonium compound, has been associated with cytotoxic and…
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 60+ 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
San Francisco, CA
www.PsychedelicNewsWire.com
415.949.5050 Office
Editor@PsychedelicNewsWire.com
PsychedelicNewsWire is powered by IBN
