---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-25-102930"
form_type: "8-K"
ticker: "NTRB"
cik: "0001676047"
company_name: "NutriBand Inc."
filed_at: "2025-10-28T23:59:59+00:00"
generated_at: "2026-05-17T01:57:02.467819+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Nutriband receives FDA feedback on AVERSA FENTANYL CMC plans; regulatory pathway confirmed as 505(b)(2)

## Summary
- FDA meeting held September 18, 2025; final minutes received; feedback on CMC, registration batch, and stability plans.
- FDA confirmed 505(b)(2) NDA path and provided guidance on reference drug bridging strategy.
- Company plans to file IND to support a Human Abuse Potential clinical study for the abuse-deterrent fentanyl patch.
- Partner Kindeva to develop AVERSA FENTANYL combining Nutriband's AVERSA technology with Kindeva's FDA-approved fentanyl patch.
- Peak annual US sales potential estimated at $80M to $200M per market analysis report.

## SEC filing metadata
- accession: 0001213900-25-102930
- form_type: 8-K
- ticker: NTRB
- cik: 0001676047
- company_name: NutriBand Inc.
- filed_at: 2025-10-28T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1676047/000121390025102930/0001213900-25-102930-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1676047/000121390025102930/ea0262795-8k_nutriband.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-25-102930
- JSON: https://secwatch.observer/filing/0001213900-25-102930.json
- Plain text: https://secwatch.observer/filing/0001213900-25-102930.txt

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