NRx Pharmaceuticals issued a press release announcing a path to New Drug Application for NRX-100 (preservative-free ketamine) for Treatment-Resistant Depression in the context of suicidality, following a Type C FDA meeting, using existing clinical data and Real World Evidence from over 65,000 patients. The company anticipates NDA submission in Q2 2026 targeting full approval.
Key takeaways
Completed in-person Type C FDA meeting on February 17, 2026 with Division of Psychiatry Products
Path to full NDA for NRX-100 based on clinical trials and Real World Evidence from 65,000 patients
Expanded indication to Treatment-Resistant Depression with suicidality
NDA submission anticipated in Q2 2026 with 2026 PDUFA date
No additional nonclinical data or bridging studies required
ANDA for preservative-free ketamine generic under review with decision in Summer 2026