NRx Pharmaceuticals filed an Abbreviated New Drug Application (ANDA) for a preservative-free intravenous ketamine formulation, targeting an expanding market estimated at $750 million. NRx 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 post-traumatic stress disorder.
Ketamine Program
NRx recently initiated a New Drug Application filing for NRX-100 (IV ketamine) for the treatment of suicidal depression, based on results from well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities. The company was awarded Fast Track Designation for development of ketamine by the US FDA as part of a protocol to treat patients with acute suicidality.
Broader Pipeline
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 a New Drug Application 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 and as a treatment for complicated urinary tract infections.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://menafn.com/1111026575/Psychedelicnewsbreaks-Nrx-Pharmaceuticals-Inc-NASDAQ-NRXP-Files-ANDA-For-Preservative-Free-IV-Ketamine-Targets-Expanding-750M-Market