---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-071070"
form_type: "8-K"
ticker: "COLL"
cik: "0001267565"
company_name: "COLLEGIUM PHARMACEUTICAL, INC"
filed_at: "2024-06-13T23:59:59+00:00"
generated_at: "2026-06-01T04:33:03.094105+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# FDA grants pediatric exclusivity for Nucynta franchise; exclusivity extended to Jan 2027

## Summary
- FDA granted pediatric exclusivity for Nucynta and Nucynta ER; Nucynta exclusivity now to Jan 3, 2027, Nucynta ER to Dec 27, 2025.
- Pediatric exclusivity adds six months on top of previously granted New Patient Population exclusivity (granted 2023).
- Collegium CMO Thomas Smith said the grant enhances the value of the Nucynta franchise and bolsters near-term outlook.
- Nucynta is approved for acute pain in adults and pediatric patients 6+; Nucynta ER for severe pain and diabetic peripheral neuropathy.

## SEC filing metadata
- accession: 0001104659-24-071070
- form_type: 8-K
- ticker: COLL
- cik: 0001267565
- company_name: COLLEGIUM PHARMACEUTICAL, INC
- filed_at: 2024-06-13T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1267565/000110465924071070/0001104659-24-071070-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1267565/000110465924071070/tm2417144d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-071070
- JSON: https://secwatch.observer/filing/0001104659-24-071070.json
- Plain text: https://secwatch.observer/filing/0001104659-24-071070.txt

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