FDA agrees to review NRX-100 NDA using clinical trials and real-world evidence

Reuters19:02

FDA agrees to review NRX-100 NDA using clinical trials and real-world evidence

NRx said the FDA provided confirmatory minutes from an in-person Type C meeting supporting a path to a New Drug Application for NRX-100 (preservative-free ketamine) for depression, including patients with suicidality. The FDA indicated it is willing to review existing adequate and well-controlled trial data along with real-world evidence from Osmind as confirmatory evidence of efficacy. NRx said the FDA did not request additional clinical trials and does not expect additional nonclinical data or bridging studies for the preservative-free formulation. The company said it plans to submit the NRX-100 NDA by June 2026.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. NRX Pharmaceuticals Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202603160700PRIMZONEFULLFEED9672424) on March 16, 2026, and is solely responsible for the information contained therein.

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