Trevi Therapeutics, Inc. 8-K

What Happened

• Trevi Therapeutics (TRVI) announced results of an End‑of‑Phase 2 meeting with the U.S. Food and Drug Administration (filed on March 9, 2026). The company said it gained overall alignment with the FDA on the development plan for idiopathic pulmonary fibrosis (IPF)‑related chronic cough and intends to pursue two pivotal Phase 3 trials of nalbuphine ER (54 mg twice daily) to support a New Drug Application (NDA). Trevi also obtained agreement on the remaining Phase 1 studies it expects to run before NDA submission.

Key Details

• Drug: nalbuphine ER tablets (54 mg, twice‑a‑day dosing).
• Trial design: two randomized, double‑blind, placebo‑controlled, multicenter, global Phase 3 trials; patients randomized 2:1 (drug:placebo).
• Timelines & size: Trial A ~300 patients, 52 weeks fixed dosing with primary endpoint at 24 weeks; Trial B ~130 patients, 12 weeks fixed dosing.
• Primary endpoint (both trials): relative change from Baseline in 24‑hour cough frequency (coughs/hour) measured by an objective cough monitor.
• Planned starts: first Phase 3 trial on track to initiate in Q2 2026; second trial in the second half of 2026. Protocols remain subject to final FDA review.

Why It Matters

• These Phase 3 trials are the pivotal studies Trevi intends to use to seek U.S. approval (NDA) for nalbuphine ER in IPF‑related chronic cough, so their design, size, endpoints and timing are material to the company’s development progress.
• The filing confirms concrete near‑term milestones (Phase 3 starts in 2026) and specific trial parameters investors can track. Outcomes and FDA review of final protocols will be key upcoming catalysts.
• The company noted forward‑looking risks (e.g., trial success, costs, timing, regulatory uncertainty and cash/runway) in the filing, meaning timelines and outcomes are subject to change.