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

NutriBand Inc.

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.

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