---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-23-046174"
form_type: "8-K"
ticker: "ATXI"
cik: "0001644963"
company_name: "AVENUE THERAPEUTICS, INC."
filed_at: "2023-04-17T23:59:59+00:00"
generated_at: "2026-06-17T01:23:39.914012+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Avenue Therapeutics announces FDA agreement on most protocol items for IV Tramadol safety study

## Summary
- Received official meeting minutes from FDA Type C meeting on March 9, 2023, for IV Tramadol.
- FDA and Avenue agree on majority of proposed protocol items for opioid-induced respiratory depression study vs IV morphine.
- FDA agrees a successful study could support complete response to second Complete Response Letter for IV Tramadol.
- Company expects to finalize protocol and potentially initiate Phase 3 safety study this year; also planning updates on AJ201 and BAER-101 programs.

## SEC filing metadata
- accession: 0001104659-23-046174
- form_type: 8-K
- ticker: ATXI
- cik: 0001644963
- company_name: AVENUE THERAPEUTICS, INC.
- filed_at: 2023-04-17T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1644963/000110465923046174/0001104659-23-046174-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1644963/000110465923046174/tm2312933d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-23-046174
- JSON: https://secwatch.observer/filing/0001104659-23-046174.json
- Plain text: https://secwatch.observer/filing/0001104659-23-046174.txt

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