NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company developing innovative treatments for suicidal depression and PTSD, is accelerating its push toward regulatory approval of NRX-100, a preservative-free intravenous ketamine formulation. “The company recently filed an application under the newly created FDA Commissioner’s National Priority Voucher (‘CNPV’) program, which promises significantly shortened review timelines for drugs that meet urgent U.S. health priorities,” reads an article discussing NRx. “In parallel, the company has filed an Abbreviated New Drug Application (‘ANDA’) for NRX-100 with a request for priority review. The two pathways, CNPV and ANDA, are expected to complement one another. Should the CNPV be granted, the drug could enter a Commissioner-led review program with integrated oversight from key FDA offices.”
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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.
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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