Trevi Therapeutics Announces Publication of Data from the Phase 2b IPF Chronic Cough Trial of nalbuphine ER in the Journal of the American Medical Association (JAMA)
Trevi Therapeutics Announces Publication of Data from the Phase 2b IPF Chronic Cough Trial of nalbuphine ER in the Journal of the American Medical Association (JAMA) |
| [22-January-2026] |
Statistically-significant reduction in the relative change from baseline in 24-hour objective cough frequency observed across all dose groups of nalbuphine ER at Week 6 with statistically-significant cough reduction as early as Week 2, the first time point measured Over 60% of nalbuphine ER-treated patients achieved at least a 50% reduction in 24-hour cough frequency at Week 6 vs baseline Patient-reported outcome measure of cough frequency was consistent with reduction observed with objective cough monitoring NEW HAVEN, Conn., Jan. 22, 2026 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy oral nalbuphine ER for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC), today announced that the key results from the Phase 2b CORAL trial of oral nalbuphine ER for the treatment of chronic cough in patients with IPF have been published in the Journal of the American Medical Association (JAMA).
"The publication of these positive Phase 2b results with nalbuphine ER in JAMA represents an important validation of the trial findings and highlights the significance of chronic cough in patients with IPF," said James Cassella, PhD, Chief Development Officer of Trevi Therapeutics. "The statistically-significant reduction in 24-hour objective cough frequency across all dose groups shows the potential that nalbuphine ER has for the treatment of chronic cough in patients with IPF. We look forward to continuing the development of nalbuphine ER, and thank all the patients, investigators, and study staff, who have participated in our clinical trials to get us to this point." Philip Molyneaux, MD, PhD, Professor of Pulmonary Medicine at the Royal Brompton Hospital, London, said, "Chronic cough continues to represent a major unmet need in the care of my patients with IPF and imposes a significant burden on their day-to-day lives. As an investigator for the trial, I was thrilled to see the consistency between objective and patient-reported outcomes, demonstrating that the patients are not only experiencing fewer objective coughs, but overall feeling an improvement as well. These results reinforce the need for continued evaluation of nalbuphine ER." Access the publication here. The safety results of the CORAL trial were generally consistent with the known safety profile of nalbuphine ER from previous trials. Discontinuation rates due to adverse events were similar in the combined nalbuphine ER dose groups (5.6%) and placebo group (5.0%). The most common adverse events experienced included: nausea, vomiting, constipation, dizziness, headache, fatigue, somnolence, and dry mouth. Serious adverse events (all non-fatal) were reported for four patients (10.0%) in the placebo group and for two patients (1.6%) treated with nalbuphine ER. About Idiopathic Pulmonary Fibrosis (IPF) Chronic Cough About the Phase 2b CORAL Trial About Trevi Therapeutics, Inc. Trevi intends to propose Haduvio as the trade name for oral nalbuphine ER. Its safety and efficacy have not been evaluated by any regulatory authority. For more information, visit www.TreviTherapeutics.com and follow Trevi on X (formerly Twitter) and LinkedIn. Investor Contact Media Contact
SOURCE Trevi Therapeutics, Inc. | ||
Company Codes: NASDAQ-NMS:TRVI,NASDAQ:TRVI |
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