NRx Pharmaceuticals has initiated its first commercial manufacturing order of preservative-free ketamine in anticipation of potential approval under the Generic Drug User Fee Act in summer 2026. The order is supported by stability data from multiple registration batches and a successful third-party manufacturing audit.
NRx Pharmaceuticals is developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The company is developing NRX-100, a preservative-free intravenous ketamine, and NRX-101, an oral combination of D-cycloserine and lurasidone. NRX-100 has been awarded Fast Track Designation from the FDA for the treatment of suicidal ideation in depression, including bipolar depression.
NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx has filed an Abbreviated New Drug Application and initiated a New Drug Application filing for NRX-100 with an application for the Commissioner’s National Priority Voucher Program for the treatment of suicidal ideation in patients with depression, including bipolar depression. The company is advancing its preservative-free ketamine formulation toward regulatory approval for addressing suicidal ideation in various depressive conditions.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.financialcontent.com/article/nnwire-2026-5-5-networknewsbreaks-nrx-pharmaceuticals-inc-nasdaq-nrxp-initiates-first-commercial-manufacturing-order-for-preservative-free-ketamine