secwatch.observer — SEC 8-K summary
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Issuer:     COLLEGIUM PHARMACEUTICAL, INC (COLL)
CIK:        0001267565
Form:       8-K
Filed at:   2023-08-24T23:59:59+00:00
Accession:  0001104659-23-094746
Event type: regulatory
Sentiment:  positive
Materiality: 0.60
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA grants Nucynta IR exclusivity extension to July 2026
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1267565/000110465923094746/0001104659-23-094746-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1267565/000110465923094746/tm2323003d2_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-23-094746

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer