NRx Pharmaceuticals (NASDAQ: NRXP) a clinical-stage biopharma company, has filed a patent application for NRX-100, its preservative-free intravenous ketamine formulation targeting suicidal depression. The patent, which includes 20 claims, could provide exclusivity through 2045 if granted. NRX-100 is designed without benzethonium chloride or other preservatives linked to toxicity and has shown room temperature shelf stability—potentially qualifying it for FDA Orange Book listing. The filing supports the company’s NDA submission strategy and complements the FDA Fast Track Designation of companion drug NRX-101.
To view the full press release, visit https://ibn.fm/aN0Ul
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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