NRx Pharmaceuticals announced receiving positive FDA feedback on its preservative-free ketamine application following President Trump’s executive order supporting accelerated approval of psychedelic medications. On April 22, the company received a Discipline Review Letter from the FDA Office of Generic Drugs covering drug substance, drug product, manufacturing, and microbiology. The letter requested only administrative changes and updates to prior stability data, all identified as “minor.” The FDA Office of Generic Drugs leadership recognized the national priority around expediting ketamine approval documented in the President’s Executive Order titled “Accelerating Medical Treatments for Serious Mental Illness.”
The company’s preservative-free ketamine presentation differs from existing products in that it does not contain Benzethonium Chloride, described as a “known toxic preservative” that is no longer allowed in new drugs and cannot be included in hand cleansers and topical antiseptics. Supply shortages of ketamine have been documented by physicians seeking it for clinical use. FDA leadership expressed support for addressing the remaining aspects of the ANDA application within the current review cycle, targeting approval in Summer 2026. The approval is particularly important because of these documented supply shortages.
NRx is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. On April 20, NRx welcomed the Executive Order signed April 18, directing the FDA to provide Commissioner’s National Priority Vouchers to appropriate psychedelic drugs with Breakthrough Therapy designation. NRXP has applied for a Commissioner’s National Priority Voucher in support of its upcoming New Drug Application for NRX-100. The company plans to submit 70,000 patient data points on real-world use of ketamine for treatment of suicidal depression to the FDA in support of NRX-100 approval. NRx also announced incorporating a Defense Systems subsidiary charged with developing neuroplastic treatments combining D-cycloserine with robotic-enabled Transcranial Magnetic Stimulation for military and first responder applications.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.financialcontent.com/article/getnews-2026-4-22-positive-fda-response-on-preservative-free-ketamine-after-president-trump-orders-accelerated-approval-for-psychedelic-medication-developers-including-nrx-pharmaceuticals-inc-nasdaq-nrxp