---
schema_version: "secwatch.filing_event.v1"
accession: "0001564590-22-003250"
form_type: "8-K"
ticker: "TRVI"
cik: "0001563880"
company_name: "Trevi Therapeutics, Inc."
filed_at: "2022-02-01T23:59:59+00:00"
generated_at: "2026-06-27T12:58:18.431605+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Trevi completes enrollment in Phase 2b/3 PRISM trial for Haduvio in prurigo nodularis; top-line data expected Q2 2022

## Summary
- 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.

## SEC filing metadata
- accession: 0001564590-22-003250
- form_type: 8-K
- ticker: TRVI
- cik: 0001563880
- company_name: Trevi Therapeutics, Inc.
- filed_at: 2022-02-01T23:59:59+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1563880/000156459022003250/0001564590-22-003250-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1563880/000156459022003250/trvi-8k_20220201.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001564590-22-003250
- JSON: https://secwatch.observer/filing/0001564590-22-003250.json
- Plain text: https://secwatch.observer/filing/0001564590-22-003250.txt

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