NRXP News & Events

NRx Pharmaceuticals announced receipt of clearance from the FDA to initiate a clinical trial of NRX-101 vs. placebo in patients with depression and suicidality who are being treated with either Robotic-assisted Transcranial Magnetic Stimulation or sham TMS. The placebo-controlled phase 2/3 trial is identified as A Randomized, Double-Blind, Three-Arm Study of NRX-101 as Adjunctive Therapy to Active or Sham Transcranial Magnetic Stimulation in Adults with Treatment Resistant Major Depressive Disorder.

NRx Pharmaceuticals announced the initiation of its first commercial manufacturing order of its preservative-free ketamine product in anticipation of approval in Summer 2026. "NRx thanks its manufacturing partner for the care and support that has been invested in this project and looks forward to being able to serve Americans with a safe and convenient US-made ketamine product," said Jonathan Javitt, chairman and CEO of NRx Pharmaceuticals. The order is based on stability observed in more than three manufactured registration batches and the company's successful third-party audit of the manufacturing facility. NRx expects the initial manufacturing pace will be sufficient to support initial substantial yearly revenues and notes the ability to rapidly scale manufacturing as demand grows. The product is the first U.S.-manufactured preservative-free ketamine presentation, utilizing a blow-fill-seal process that achieves more than 10-fold higher manufacturing throughput than traditional sterile bottling techniques.

NRx Pharmaceuticals announced the receipt of a discipline review letter from the FDA Office of Generic Drugs and the completion of a meeting with leadership. The discipline review letter entitled "Quality" covers the areas of drug substance, drug product, manufacturing and microbiology. The letter requests only administrative changes and updates to prior stability data, all of which are identified as "minor." This review letter follows the previously announced bioequivalence determination from the FDA Office of Generic Drugs on March 17 and represents a separate review discipline within the ANDA process. NRx additionally conducted a meeting with leadership of the FDA Office of Generic Drugs in which the national priority around expediting approval of ketamine, now documented in the President's April 16 executive order, was recognized by FDA leadership. The executive order calls for expedited approval of drugs to treat severe depression and suicidality. The company said the approval of the preservative-free ketamine ANDA is particularly important because of supply shortages documented by physicians who seek to obtain ketamine for use in the clinic setting. FDA leadership expressed support for addressing the remaining aspects of the current ANDA application within the current review cycle that targets approval in Summer 2026.