NRx Pharmaceuticals announced it has completed a Type C guidance meeting with the FDA regarding its investigational ketamine treatment NRX-100. Based on the meeting, the company believes it has a path to filing a New Drug Application for the medication using data from clinical trials combined with real-world evidence from more than 65,000 patients.
The FDA guidance indicates that no additional nonclinical data would be required and no bridging studies would be needed to support NRX-100’s preservative-free formulation compared to currently approved preservative-containing ketamine. NRx will seek a broader indication to serve patients with treatment-resistant depression in the context of suicidality, rather than only patients with suicidality alone.
According to Dr. Jonathan Javitt, founder, Chairman, and CEO of NRx Pharmaceuticals, the company will use the clinical trial data already in hand together with the proposed real-world data from Osmind, Inc. to apply for approval of NRX-100. The company stated it would work collaboratively with the FDA in the coming weeks to finalize the statistical analysis protocol for the full 65,000-person real-world evidence dataset.
NRX-100 has been awarded Fast Track Designation for the treatment of suicidal ideation in depression, including bipolar depression. The company is also developing NRX-101, an oral D-cycloserine/lurasidone combination that has received Breakthrough Therapy Designation for the treatment of suicidal bipolar depression.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.globenewswire.com/news-release/2026/02/17/3239083/0/en/NRx-Pharmaceuticals-Nasdaq-NRXP-Announces-Path-to-New-Drug-Application-with-Real-World-Data-and-Broader-Proposed-Indication-for-NRX-100-ketamine-Following-Type-C-FDA-Meeting.html