Core Insights - Trevi Therapeutics, Inc. is advancing its investigational therapy Haduvio™ (oral nalbuphine ER) for chronic cough associated with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC) [1][5] - Data from the Phase 2a RIVER trial will be presented at the European Respiratory Society (ERS) Congress 2025, highlighting the efficacy and safety of nalbuphine ER in treating RCC [1][2] Company Overview - Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for chronic cough, with Haduvio being the first investigational therapy to demonstrate a statistically significant reduction in cough frequency in clinical trials for both IPF and RCC patients [5][6] - Haduvio acts on the cough reflex arc as a kappa agonist and mu antagonist (KAMA), targeting opioid receptors involved in chronic cough control [5] Clinical Trial Details - The Phase 2a RIVER trial was a randomized, double-blind, placebo-controlled study designed to assess the efficacy, safety, and tolerability of nalbuphine ER in RCC patients, with treatment periods lasting 21 days and a primary endpoint focused on the mean change in 24-hour cough frequency [3][4] - The trial included a full analysis set (FAS) population, which consisted of patients who received at least one dose of the study drug and had objective cough count data [3] Market Need - RCC is characterized by a persistent cough lasting over 8 weeks despite treatment for underlying conditions, affecting approximately 2-3 million patients in the U.S. [4] - There are no FDA-approved therapies for RCC, indicating a significant unmet medical need in this patient population [4] Impact of Chronic Cough - Chronic cough in patients with IPF and non-IPF ILD is prevalent, with around 150,000 U.S. patients with IPF and 228,000 with non-IPF ILD, where 50-60% experience uncontrolled chronic cough [6] - The condition can lead to severe morbidity and a decline in quality of life, with patients potentially coughing up to 1,500 times per day [6]