Nalbuphine Hydrochloride

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 Jan. 22, 2026 -- 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." 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. Chronic cough in patients with IPF is a condition with high unmet need and no FDA-approved therapies. There are ~150,000 U.S. patients with IPF, and two-thirds of these patients are faced with uncontrolled chronic cough. The impact of chronic cough is significant, with patients coughing up to 1,500 times per day. This consistent cough, and any associated damage, may lead to a higher risk of morbidity and mortality, including worsening disease, a higher risk of progression, increased respiratory hospitalizations, and a decline in patients' quality of life. The Phase 2b Cough Reduction in IPF with nalbuphine ER (CORAL) trial was a double-blind, randomized, placebo-controlled, parallel-arm trial evaluating three doses of nalbuphine ER (27 mg, 54 mg, and 108 mg twice daily) compared to placebo for the treatment of chronic cough in patients with IPF over a 6-week treatment period. 165 patients with IPF chronic cough were randomized 1:1:1:1 to one of three nalbuphine ER dose groups or placebo with an initial 2-week titration period to the target dose followed by 4 weeks of fixed dosing. The primary efficacy endpoint for the trial was the relative change in 24-hour cough frequency (coughs per hour), as determined by an objective cough monitor, for the modified intent-to-treat (mITT) population at the end of Week 6 versus Baseline for nalbuphine ER compared to placebo. The mITT population consisted of all patients who were randomized and received at least one dose of study drug or placebo. Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine extended-release) 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). Haduvio is the first and only investigational therapy to show a statistically-significant reduction in cough frequency in clinical trials across both patients with IPF chronic cough and in patients with RCC. Haduvio acts on the cough reflex arc both centrally and peripherally as a kappa agonist and a mu antagonist (KAMA), targeting opioid receptors that play a key role in controlling chronic cough. Nalbuphine is not currently scheduled by the U.S. Drug Enforcement Agency. 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. 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