secwatch.observer — SEC 8-K summary
======================================

Issuer:     Trevi Therapeutics, Inc. (TRVI)
CIK:        0001563880
Form:       8-K
Filed at:   2024-12-03T23:59:59+00:00
Accession:  0000950170-24-132883
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Trevi Therapeutics announces positive HAP study results for oral nalbuphine; primary endpoint met at clinical doses
--------------------------------------------------------------------------------

- Primary endpoint: mean Emax for 'Drug Liking' for oral nalbuphine 81mg was 71.2 vs IV butorphanol 6mg (82.3), p<0.0001.
- Oral nalbuphine 162mg also statistically significant (74.5 vs 82.3, p=0.0008); 486mg supratherapeutic dose not significant (p=0.3221).
- No serious adverse events reported; secondary endpoints (e.g., 'Take Drug Again,' 'I Feel High') consistent with primary result.
- Results will be included in 8-factor abuse potential analysis for nalbuphine ER as part of planned NDA submission.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1563880/000095017024132883/0000950170-24-132883-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1563880/000095017024132883/trvi-20241203.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-132883

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