Professor Philip Molyneaux will give an oral presentation on the key efficacy and safety results from the Phase 2b CORAL trial of nalbuphine ER for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF)
Associate Professor Imran Satia will give a poster presentation on the patient-reported outcomes from the Phase 2a RIVER trial of nalbuphine ER for the treatment of patients with refractory chronic cough (RCC)
NEW HAVEN, Conn., Oct. 8, 2025 /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 the acceptance of two abstracts for presentation at the CHEST 2025 Annual Meeting, to be held from October 19 to 22 in Chicago, Illinois. The key safety and efficacy results from the Phase 2b CORAL dose-ranging trial of nalbuphine ER for the treatment of chronic cough in patients with IPF was accepted for oral presentation. Additionally, patient-reported outcome results from the Phase 2a RIVER proof-of-concept trial of nalbuphine ER for the treatment of patients with RCC will be featured as a poster presentation.
Abstract: A randomized, placebo-controlled, parallel-group phase 2b trial of nalbuphine extended-release for chronic cough in patients with idiopathic pulmonary fibrosis
Oral Presentation Session: Pulmonary Fibrosis: Advances in Pharmacotherapy Late-Breaking Scientific Abstracts
Session Date & Time: October 21, 1:45-2:30pm CDT
Location: Exhibit Hall Rapid Fire Area 4B
Oral Presenter: Philip Molyneaux, MD, PhD
Abstract: Patient-reported outcomes from a phase 2a trial of extended-release nalbuphine for patients with refractory chronic cough
Poster Session: Late-Breaking Scientific Abstracts Posters: Guidelines, Diffuse Lung Disease, Pulm Vasc Disease and More
Session Date & Time: October 21, 1:45-2:30pm CDT
Location: Exhibit Hall Poster Area 6
Poster Presenter: Imran Satia, MB, BChir, PhD, MRCP
About the Phase 2b CORAL Trial
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 (BID)) 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.
About the Phase 2a RIVER Trial
The 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 of nalbuphine ER for the treatment of patients with RCC. Each treatment period lasted 21 days, separated by a 21-day washout period. During the nalbuphine ER treatment period, patients were titrated with assessments at 27 mg 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 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 a 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.
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.
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
Jonathan Carlson
Trevi Therapeutics, Inc.
(203) 654 3286
carlsonj@trevitherapeutics.com
Media Contact
Rosalia Scampoli
914-815-1465
rscampoli@marketcompr.com
SOURCE Trevi Therapeutics, Inc.
