FDA grants Fast Track Designation to NRX-100 for suicidal ideation treatment.

NRX-100, a preservative-free ketamine, has been granted Fast Track Designation by the FDA for treating suicidal ideation in patients with depression and bipolar depression. The designation is based on real-world evidence from Osmind's nationwide electronic medical records-derived dataset. Preliminary analysis of a 20,000 patient subset showed rapid resolution of depression and suicidality with intravenous ketamine. The results are consistent with prior randomized trial data and compare favorably to currently-approved products. An upcoming analysis of the full 70,000 patient Real World Data set will be presented to the FDA in support of Accelerated Approval.