NRx Pharmaceuticals (NASDAQ: NRXP), has submitted an Abbreviated New Drug Application (ANDA) to the FDA for NRX-100, its preservative-free intravenous ketamine formulation aimed at approved indications such as anesthesia and pain management. With the U.S. ketamine market valued at $750 million and global demand projected to reach $3.35 billion by 2034, the company is seeking priority review amid an ongoing national shortage. NRx also plans to petition the FDA to mandate preservative-free ketamine formulations, citing safety concerns over benzethonium chloride. This filing complements its broader strategy to expand ketamine’s label to include treatment for suicidal depression, backed by clinical data from more than 1,000 patients.
To view the full press release, visit https://ibn.fm/ZBVfa
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 US 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 US FDA as part of a protocol to treat patients with acute suicidality.
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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