---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-23-094746"
form_type: "8-K"
ticker: "COLL"
cik: "0001267565"
company_name: "COLLEGIUM PHARMACEUTICAL, INC"
filed_at: "2023-08-24T23:59:59+00:00"
generated_at: "2026-06-11T03:54:59.422532+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# FDA grants Nucynta IR exclusivity extension to July 2026

## Summary
- FDA granted New Patient Population exclusivity for Nucynta (tapentadol IR), extending U.S. exclusivity from June 27, 2025 to July 3, 2026.
- Extension based on pediatric trial data submitted per FDA Pediatric Written Request for pain treatment in patients aged 6+.
- Collegium continues pursuit of pediatric extension for entire Nucynta Franchise, which could add six months for Nucynta ER and IR.
- Nucynta is approved for acute pain severe enough to require an opioid analgesic in adults and pediatric patients weighing ≥40 kg.

## SEC filing metadata
- accession: 0001104659-23-094746
- form_type: 8-K
- ticker: COLL
- cik: 0001267565
- company_name: COLLEGIUM PHARMACEUTICAL, INC
- filed_at: 2023-08-24T23:59:59+00:00
- event_type: regulatory
- 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/1267565/000110465923094746/0001104659-23-094746-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1267565/000110465923094746/tm2323003d2_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-23-094746
- JSON: https://secwatch.observer/filing/0001104659-23-094746.json
- Plain text: https://secwatch.observer/filing/0001104659-23-094746.txt

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