secwatch.observer — SEC 8-K summary
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Issuer:     Trevi Therapeutics, Inc. (TRVI)
CIK:        0001563880
Form:       8-K
Filed at:   2022-02-01T23:59:59+00:00
Accession:  0001564590-22-003250
Event type: other_material
Sentiment:  neutral
Materiality: 0.60
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Trevi completes enrollment in Phase 2b/3 PRISM trial for Haduvio in prurigo nodularis; top-line data expected Q2 2022
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- PRISM trial enrolled ~360 subjects with severe pruritus and prurigo nodularis.
- Trial evaluates Haduvio (nalbuphine ER) 162 mg versus placebo twice daily.
- Primary endpoint: ≥4-point improvement in weekly mean WI-NRS at Week 14 vs baseline.
- FDA previously granted Fast Track designation for nalbuphine ER in PN pruritus.
- Top-line data expected in Q2 2022.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1563880/000156459022003250/0001564590-22-003250-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1563880/000156459022003250/trvi-8k_20220201.htm
  HTML page:      https://secwatch.observer/filing/0001564590-22-003250

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