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# FDA Will Review Ketamine-Based Drug Without New Trials: NRx
- URL: https://www.fdaweb.com/fda-will-review-ketamine-based-drug-without-new-trials-nrx/
- Published: 2026-03-16T12:00:00.000Z
- Updated: 2026-09-14T13:35:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160823

NRx Pharmaceuticals says it has received meeting minutes from a recent Type C guidance meeting with FDA indicating it is willing to review a potential NDA for its investigational therapy NRX-100, a preservative-free intravenous formulation of ketamine, without requiring additional clinical trials.

According to the company, the meeting involved officials from the FDA’s Division of Psychiatry Products, Office of Neuroscience and Center for Drug Evaluation and Research. The minutes confirm that regulators would consider existing clinical trial data as “substantial evidence of effectiveness” to support a future application, provided that the company submits detailed patient-level datasets for review.

NRx said the agency also indicated they would consider real-world evidence as supportive confirmation of the therapy’s efficacy.

The company plans to seek approval of NRX-100 for treating severe depression in patients who may experience suicidal ideation, expanding beyond its earlier strategy of targeting only patients with suicidal thoughts.

Ketamine has been studied for rapid-acting antidepressant effects and reduction of suicidal ideation. NRx says clinical trials reviewed during the meeting showed the drug demonstrated superiority to placebo and active placebo and was non-inferior to electroconvulsive therapy, the only currently approved treatment specifically indicated for suicidal ideation. The company also says the therapy showed statistically significant reductions in suicidal thoughts without the memory-loss side effects often associated with electroconvulsive therapy.

According to the company, FDA also confirmed that additional nonclinical studies would not be required to support the proposed application and that no bridging studies would be necessary for the preservative-free formulation, which NRx said may have at least three years of room-temperature shelf stability.