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NEW HAVEN, Conn.,Sept. 18, 2025/PRNewswire/ --Trevi Therapeutics, Inc.(Nasdaq:TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (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 data from the Phase 2a RIVER trial of nalbuphine ER for the treatment of patients with RCC, will be highlighted in two poster presentations at theEuropean Respiratory Society (ERS) Congress 2025. ERS will be held fromSeptember 27 to October 1inAmsterdam, Netherlands.
Abstract:Late Breaking Abstract - Efficacy and safety of nalbuphine extended-release in refractory chronic cough: results from the phase 2a RIVER trialPoster Session:305 – Rethinking Cough: From Mechanism to ManagementSession Date & Time:September 29,12:30-2:00pm CESTLocation:PS-14
Abstract:Late Breaking Abstract - Responder analysis of nalbuphine extended-release in refractory chronic cough: results from the RIVER phase 2a trialPoster Session:158 – Lung Physiology in Interstitial Lung DiseaseSession Date & Time:September 28,12:30-2:00pm CESTLocation:PS-6
Registration Details
About the Phase 2a RIVER TrialThe Phase 2a Refractory Chronic Cough Improvement Via Nalbuphine ER (RIVER) trial was a randomized, double-blind, placebo-controlled, two-treatment, two-period, crossover study designed to evaluate the efficacy, safety, and tolerability ofnalbuphine ERfor the treatment of patients with RCC. Each treatment period lasted 21 days, separated by a 21-day washout period. During thenalbuphine ERtreatment period, patients were titrated with assessments at 27 mg twice daily (BID), 54 mg BID, and 108 mg BID for objective cough and other assessments at each dose. The primary endpoint of the trial was the mean change in 24-hour cough frequency, as determined by an objective cough monitor, for the full analysis set (FAS) population at Day 21. The FAS population included all patients who received at least one dose of study drug and have objective cough count data on both Baseline and Day 21 in at least one treatment period.
About Refractory Chronic Cough (RCC)Refractory chronic cough is a condition with high unmet need and no FDA-approved therapies. RCC is defined as a persistent cough lasting >8 weeks despite treatment for an underlying condition (i.e., asthma, gastroesophageal reflux disease, non-asthmatic eosinophilic bronchitis, upper airway cough syndrome, or post-nasal drip) and includes unexplained chronic cough. There are ~2-3 million U.S. patients with RCC, and it is believed to be associated with cough reflex hypersensitivity involving both the central and peripheral nervous systems. RCC is highly debilitating and may impact patients physically, psychologically, and socially.
About Trevi Therapeutics, Inc.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 of 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.
Chronic cough in patients with IPF and non-IPF ILD 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. Additionally, there are ~228,000 U.S. patients with non-IPF ILD, with 50-60% having 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.
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, visitwww.TreviTherapeutics.comand follow Trevi onX(formerly Twitter) andLinkedIn.
Investor ContactJonathan CarlsonTrevi Therapeutics, Inc.(203) 654 3286[email protected]
Media ContactRosalia Scampoli914-815-1465[email protected]
SOURCE Trevi Therapeutics, Inc.