Core Insights - Trevi Therapeutics announced positive results from the Phase 2b CORAL trial for oral nalbuphine ER, showing a statistically significant reduction in 24-hour objective cough frequency in patients with idiopathic pulmonary fibrosis (IPF) [1][2] - Over 60% of patients treated with nalbuphine ER achieved at least a 50% reduction in cough frequency at Week 6 compared to baseline [1] - The trial results were published in the Journal of the American Medical Association (JAMA), validating the findings and emphasizing the unmet need for chronic cough treatment in IPF patients [2] Company Overview - Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing Haduvio (oral nalbuphine ER) for chronic cough in patients with IPF, non-IPF interstitial lung disease, and refractory chronic cough [6] - Haduvio is the first investigational therapy to demonstrate a statistically significant reduction in cough frequency in clinical trials for both IPF chronic cough and refractory chronic cough [6] Trial Details - The Phase 2b CORAL trial was a double-blind, randomized, placebo-controlled study involving 165 patients, evaluating three doses of nalbuphine ER (27 mg, 54 mg, and 108 mg) over a 6-week period [5] - The primary efficacy endpoint was the relative change in 24-hour cough frequency, measured objectively, at the end of Week 6 compared to baseline [5] Safety Profile - The safety results of the CORAL trial were consistent with the known safety profile of nalbuphine ER, with discontinuation rates due to adverse events being similar between nalbuphine ER (5.6%) and placebo (5.0%) groups [3] - Common adverse events included nausea, vomiting, constipation, dizziness, headache, fatigue, somnolence, and dry mouth [3] Industry Context - Chronic cough in patients with IPF represents a significant unmet medical need, with approximately 150,000 patients in the U.S. and two-thirds experiencing uncontrolled chronic cough [4] - The impact of chronic cough is profound, with patients potentially coughing up to 1,500 times per day, leading to increased morbidity and a decline in quality of life [4]