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Trevi Therapeutics, Inc. (TRVI) filed an 8-K current report with the SEC on March 9, 2026 reporting Item 8.01 (Other Events). FDA End-of-Phase 2 meeting yielded full alignment on IPF-related chronic cough development plan: key regulatory de-risking milestone.
Trevi Therapeutics, Inc. 8-K event analysis
AI summary of each reported item and its exhibits
Item 8.01 · Other Events
- FDA End-of-Phase 2 meeting yielded full alignment on IPF-related chronic cough development plan: key regulatory de-risking milestone
- Two pivotal Phase 3 trials to run in parallel: ~300-patient/52-week trial (primary endpoint at 24 weeks) + ~130-patient/12-week trial
- Drug: nalbuphine ER tablets at 54 mg BID; 2:1 randomization (active vs placebo); primary endpoint = objective 24-hour cough frequency change
- Phase 3 trial 1 initiating Q2 2026; trial 2 initiating H2 2026: parallel execution compresses timeline to potential NDA submission
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