BioMedNewsBreaks — NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Granted FDA Waiver for $4.3 Million NDA Filing Fee for NRX-100

NRx Pharmaceuticals (NASDAQ: NRXP) announced it has received a $4.3 million New Drug Application filing fee waiver from the FDA for NRX-100, its preservative-free ketamine therapy for suicidal depression. The waiver, granted to small businesses and drugs deemed essential for public health, enables NRx to complete its NDA by the end of Q2 2025 using existing resources. NRX-100 offers a single-patient ketamine formulation without benzethonium chloride, a preservative associated with neurotoxicity. The company aims to secure FDA approval to provide insurance-covered treatment options beyond current off-label use. 

To view the full press release, visit https://ibn.fm/C6SGv 

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. 

For more information, please visit https://www.nrxpharma.com/ 

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