---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-25-029907"
form_type: "8-K"
ticker: "NRXP"
cik: "0001719406"
company_name: "NRX Pharmaceuticals, Inc."
filed_at: "2025-09-26T23:59:59+00:00"
generated_at: "2026-05-17T05:34:31.452729+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# FDA grants Suitability Petition for NRx's preservative-free ketamine, enabling ANDA re-filing

## Summary
- FDA approved Suitability Petition for proposed strength of NRx's single-patient, preservative-free ketamine (KETAFREE™).
- Currently marketed ketamine uses multi-dose vials with toxic preservative Benzethonium Chloride; KETAFREE™ is preservative-free.
- Suitability Petition grant enables immediate re-filing of Abbreviated New Drug Application (ANDA) for KETAFREE™.
- NRx estimates total ketamine market at $750M; product aligns with FDA/HHS policy on removing toxic preservatives.
- NRx CEO noted rapid FDA response after company attended listening session with FDA Commissioner.

## SEC filing metadata
- accession: 0001437749-25-029907
- form_type: 8-K
- ticker: NRXP
- cik: 0001719406
- company_name: NRX Pharmaceuticals, Inc.
- filed_at: 2025-09-26T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1719406/000143774925029907/0001437749-25-029907-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1719406/000143774925029907/nrxp20250926_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-25-029907
- JSON: https://secwatch.observer/filing/0001437749-25-029907.json
- Plain text: https://secwatch.observer/filing/0001437749-25-029907.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.