Trevi Therapeutics Presents Nalbuphine ER Data at Major Respiratory Conferences Following Positive Phase 2 Trials
Key Insights
Trevi Therapeutics will present data from Phase 2a RIVER trial of nalbuphine ER for refractory chronic cough at the European Respiratory Society Congress 2025 through two poster presentations.
The company's Phase 2b CORAL trial results for chronic cough in idiopathic pulmonary fibrosis patients will be featured in an oral presentation at CHEST 2025 Annual Meeting.
Nalbuphine ER represents the first investigational therapy to demonstrate statistically significant reduction in cough frequency for both IPF chronic cough and refractory chronic cough patients.
Trevi Therapeutics, Inc. (Nasdaq: TRVI) announced that clinical data from its investigational therapy nalbuphine ER will be highlighted at two major respiratory medicine conferences, showcasing results from Phase 2 trials targeting chronic cough conditions with significant unmet medical needs.
The clinical-stage biopharmaceutical company will present findings from both its Phase 2a RIVER trial for refractory chronic cough (RCC) and Phase 2b CORAL trial for chronic cough in idiopathic pulmonary fibrosis (IPF) patients at the European Respiratory Society (ERS) Congress 2025 and CHEST 2025 Annual Meeting, respectively.
Phase 2a RIVER Trial Results Featured at ERS Congress
Two poster presentations from the RIVER trial will be showcased at ERS Congress 2025, held September 27 to October 1 in Amsterdam, Netherlands. The presentations will focus on efficacy and safety data as well as responder analysis from the randomized, double-blind, placebo-controlled crossover study.
The RIVER trial evaluated nalbuphine ER in patients with RCC using a two-treatment, two-period crossover design. Each treatment period lasted 21 days, separated by a 21-day washout period. During the nalbuphine ER treatment period, patients were titrated through assessments at 27 mg twice daily (BID), 54 mg BID, and 108 mg BID. The primary endpoint measured mean change in 24-hour cough frequency using an objective cough monitor for the full analysis set population at Day 21.
Phase 2b CORAL Trial Data at CHEST 2025
Professor Philip Molyneaux will deliver an oral presentation on key efficacy and safety results from the Phase 2b CORAL trial at the CHEST 2025 Annual Meeting in Chicago, October 19-22. Additionally, Associate Professor Imran Satia will present patient-reported outcomes from the RIVER trial as a poster presentation.
The CORAL trial was a double-blind, randomized, placebo-controlled, parallel-arm study evaluating three doses of nalbuphine ER (27 mg, 54 mg, and 108 mg BID) compared to placebo over a 6-week treatment period. The study randomized 165 patients with IPF chronic cough in a 1:1:1:1 ratio, with an initial 2-week titration period followed by 4 weeks of fixed dosing. The primary efficacy endpoint assessed relative change in 24-hour cough frequency for the modified intent-to-treat population at Week 6 versus baseline.
Addressing Significant Unmet Medical Need
Nalbuphine ER, proposed under the trade name Haduvio™, represents the first and only investigational therapy to demonstrate statistically significant reduction in cough frequency in clinical trials of both IPF chronic cough and RCC patients. The drug acts on the cough reflex arc both centrally and peripherally as a kappa agonist and mu antagonist (KAMA), targeting opioid receptors that play a key role in controlling chronic cough.
The conditions addressed by nalbuphine ER represent substantial unmet medical needs. Refractory chronic cough affects approximately 2-3 million U.S. patients and is defined as persistent cough lasting more than 8 weeks despite treatment for underlying conditions such as asthma, gastroesophageal reflux disease, or upper airway cough syndrome. RCC is associated with cough reflex hypersensitivity involving both central and peripheral nervous systems and can be highly debilitating, impacting patients physically, psychologically, and socially.
For IPF patients, chronic cough affects approximately 150,000 U.S. patients, with two-thirds facing uncontrolled chronic cough. Additionally, among the 228,000 U.S. patients with non-IPF interstitial lung disease, 50-60% experience uncontrolled chronic cough. The impact is significant, with patients coughing up to 1,500 times per day, potentially leading to higher risk of morbidity and mortality, disease progression, increased respiratory hospitalizations, and declined quality of life.
Currently, no FDA-approved therapies exist for chronic cough in patients with IPF, non-IPF ILD, or refractory chronic cough, highlighting the critical need for effective treatment options. Nalbuphine is not currently scheduled by the U.S. Drug Enforcement Agency, and the safety and efficacy of nalbuphine ER have not yet been evaluated by any regulatory authority.