---
schema_version: "secwatch.filing_event.v1"
accession: "0001628280-24-051956"
form_type: "8-K"
ticker: "AQST"
cik: "0001398733"
company_name: "Aquestive Therapeutics, Inc."
filed_at: "2024-12-19T23:59:59+00:00"
generated_at: "2026-05-29T01:22:32.899545+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# FDA grants Aquestive 7-year orphan drug exclusivity for Libervant in pediatric seizure clusters ages 2-5

## Summary
- FDA granted 7 years of orphan drug exclusivity to Libervant (diazepam) Buccal Film for treating seizure clusters in patients aged 2-5.
- Exclusivity extends to April 2031; FDA cited buccal route as major contribution to patient care vs rectal route.
- Libervant is the first and only FDA-approved orally administered rescue therapy for this pediatric population.
- Originally designated as orphan drug in 2016; ODE now granted following approval on April 26, 2024.

## SEC filing metadata
- accession: 0001628280-24-051956
- form_type: 8-K
- ticker: AQST
- cik: 0001398733
- company_name: Aquestive Therapeutics, Inc.
- filed_at: 2024-12-19T23:59:59+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/1398733/000162828024051956/0001628280-24-051956-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1398733/000162828024051956/aqst-20241219.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001628280-24-051956
- JSON: https://secwatch.observer/filing/0001628280-24-051956.json
- Plain text: https://secwatch.observer/filing/0001628280-24-051956.txt

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