secwatch.observer — SEC 8-K summary
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Issuer:     Trevi Therapeutics, Inc. (TRVI)
CIK:        0001563880
Form:       8-K
Filed at:   2026-03-09T23:59:59+00:00
Accession:  0001193125-26-098676
Event type: regulatory
Sentiment:  positive
Materiality: 0.80
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Trevi Therapeutics gains FDA alignment on Phase 3 plan for nalbuphine ER in IPF cough; first trial Q2 2026
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- End-of-Phase 2 FDA meeting: overall alignment on IPF-related chronic cough development program including two pivotal Phase 3 trials and Phase 1 studies for NDA support.
- First Phase 3 trial (~300 patients, 52-week dosing, primary endpoint at 24 weeks) expected to start Q2 2026; second Phase 3 (~130 patients, 12-week dosing) in H2 2026.
- Both trials randomized, double-blind, placebo-controlled, global, evaluating nalbuphine ER 54 mg BID vs placebo with 2:1 randomization.
- Primary endpoint for both: relative change from baseline in 24-hour cough frequency measured by objective cough monitor.
- Trial designs are subject to final FDA protocol review.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1563880/000119312526098676/0001193125-26-098676-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1563880/000119312526098676/trvi-20260309.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-098676

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