NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, has re-filed an Abbreviated New Drug Application (“ANDA”) for KETAFREE(TM), a preservative-free intravenous (“IV”) ketamine formulation intended for all currently approved ketamine indications. This follows FDA approval of NRx’s Suitability Petition… KETAFREE(TM) is designed to eliminate benzethonium chloride (“BZT”), a known neurotoxic and cytotoxic preservative still present in many ketamine formulations. NRx previously submitted a Citizen Petition urging the FDA to ban BZT from all IV ketamine products, citing long-term health risks and filing supporting toxicology evidence… In parallel, NRx is advancing NRX-100, a separate preservative-free ketamine formulation, under a New Drug Application (“NDA”) for treatment of suicidal depression, including bipolar depression. NRX-100 has received Fast Track Designation, and the company aims to qualify for the FDA’s National Priority Voucher Program. The two products—KETAFREE(TM) and NRX-100—will follow distinct regulatory and commercial paths. NRx is also developing NRX-101, an oral medication for suicidal bipolar depression, which holds Breakthrough Therapy Designation. With rising demand for ketamine and ongoing drug shortages, NRx aims to capture a significant market share while setting a new standard in preservative-free IV formulations.
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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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