NRx Pharmaceuticals completed an in-person FDA Type C meeting regarding NRX-100, a preservative-free ketamine formulation for suicidal depression. The company received guidance on a path to file a New Drug Application based on existing trial data and Real World Evidence from over 65,000 patients.
NRx Pharmaceuticals completed a Type C meeting with the FDA, receiving guidance to file a New Drug Application for NRX-100 based on existing trial data and real-world evidence from over 65,000 patients, with submission planned for Q2 2026.
NRx Pharmaceuticals completed a Type C meeting with FDA leadership and received oral guidance supporting a New Drug Application for NRX-100 (preservative-free ketamine) based on existing trial data and Real World Evidence from over 65,000 patients.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT04813835 |
Cognition, Sleep, Neurophysiology of Suicidal Depressed Patients |
COMPLETED | |
| NCT03014362 |
TMS for Suicidal Crisis in Active Duty SMs |
COMPLETED | NA |
