---
schema_version: "secwatch.filing_event.v1"
accession: "0001356576-25-000002"
form_type: "8-K"
ticker: "SUPN"
cik: "0001356576"
company_name: "SUPERNUS PHARMACEUTICALS, INC."
filed_at: "2025-01-27T23:59:59+00:00"
generated_at: "2026-05-27T09:05:59.344109+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Supernus announces FDA label update for Qelbree with new pharmacodynamic and lactation data

## Summary
- FDA approved updated Qelbree label including serotonin 5-HT2C partial agonist activity and norepinephrine transporter inhibition data.
- New lactation data show transfer of viloxazine into breastmilk is low; relative infant dose ~1% of maternal dose.
- Qelbree is first ADHD treatment to receive labeling approval under 2019 FDA guidance on Clinical Lactation Studies.
- Label update applies to Qelbree (viloxazine extended-release capsules) for ADHD in patients 6 years and older.
- Company cites commitment to building evidence for Qelbree use in ADHD.

## SEC filing metadata
- accession: 0001356576-25-000002
- form_type: 8-K
- ticker: SUPN
- cik: 0001356576
- company_name: SUPERNUS PHARMACEUTICALS, INC.
- filed_at: 2025-01-27T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- 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/1356576/000135657625000002/0001356576-25-000002-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1356576/000135657625000002/supn-20250127.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001356576-25-000002
- JSON: https://secwatch.observer/filing/0001356576-25-000002.json
- Plain text: https://secwatch.observer/filing/0001356576-25-000002.txt

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