- 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 neurotoxic effects. It is no longer considered Generally Recognized as Safe and Effective (“GRASE”) for parenteral or topical pharmaceutical use. The European Medicines Agency has already discouraged its use in injectable drugs, and the FDA previously removed it from topical antiseptics and hand cleansers over safety concerns.
NRx has been active in petitioning for regulatory reform on this issue. The company previously filed a Citizen Petition urging the FDA to ban BZT from all IV ketamine products, citing published toxicology data and potential long-term neurological risks.
By developing KETAFREE(TM), NRx aims to provide a safer and fully compliant version of ketamine for both hospital and outpatient use, at a time when supply constraints and rising demand have challenged healthcare providers.
Alongside the ANDA pathway for KETAFREE(TM), NRx is advancing NRX-100, a separate preservative-free ketamine product, under a New Drug Application (“NDA”) for the treatment of suicidal depression, including bipolar depression. The formulation has been granted Fast Track Designation by the FDA, positioning it for potential expedited review.
NRX-100 builds upon data from controlled clinical studies supported by the U.S. National Institutes of Health, as well as new datasets licensed from French health authorities. The company expects NRX-100 to qualify for consideration under the FDA’s National Priority Voucher Program, which supports therapies that address urgent public health needs.
In addition to its clinical progress, NRx has filed a new patent covering its preservative-free manufacturing process. The company’s approach challenges longstanding assumptions that benzethonium chloride or similar agents are necessary to maintain the sterility and stability of injectable ketamine products. If validated, this process could set a new benchmark for how future IV formulations are developed and manufactured across the broader pharmaceutical sector.
NRx also continues to advance NRX-101, an oral investigational therapy combining D-cycloserine and lurasidone, designed for patients with suicidal bipolar depression. The treatment has received FDA Breakthrough Therapy Designation and is being evaluated for potential accelerated approval. Beyond depression, NRX-101 is also being studied as a non-opioid treatment for chronic pain and potentially for complicated urinary tract infections.
At the recent Noble Capital Markets Emerging Growth Virtual Equity Conference on October 8, CEO Dr. Jonathan Javitt presented updates on the company’s research pipeline, including a forthcoming low-dose extended-release D-cycloserine (“DCS”) product designed to enhance the effects of transcranial magnetic stimulation (“TMS”) in depression therapy (https://ibn.fm/NMFPY).
Dr. Javitt also highlighted the company’s collaborations with the U.S. Department of Veterans Affairs to explore treatment options for veterans suffering from suicidal depression and PTSD. These initiatives align with NRx’s broader strategy of developing NMDA-based therapeutics aimed at improving mental health outcomes.
The company’s timing coincides with a period of heightened demand for ketamine therapies in the U.S. and abroad. Ketamine’s use has expanded from anesthesia to mental health, where its fast-acting antidepressant properties have shown promise in treatment-resistant cases. Yet supply limitations and safety concerns over preservatives have hindered broader adoption.
By developing preservative-free formulations such as KETAFREE(TM) and NRX-100, NRx is positioning itself to meet this demand while addressing a significant public health gap in formulation safety.
For more information, visit the company’s website at www.NRxPharma.com.
NOTE TO INVESTORS: The latest news and updates relating to NRXP are available in the company’s newsroom at https://ibn.fm/NRXP
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