NRx Pharmaceuticals (NASDAQ: NRXP) was featured in a recent article that discussed its approach to bring preservative-free ketamine-based therapies to market, pursuing distinct regulatory and commercial pathways for both KETAFREE(TM) and NRX-100. “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,” the article reads. “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… 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.”
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About NRx Pharmaceuticals Inc.
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 U.S. 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 U.S. FDA as part of a protocol to treat patients with acute suicidality.
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