Clinical-stage biopharmaceutical company Trevi Therapeutics, Inc. (Nasdaq:TRVI) announced on Monday that it has completed enrollment in its Phase 2a RIVER trial, evaluating Haduvio (oral nalbuphine ER) for refractory chronic cough (RCC).

Topline data is expected in Q1 2025. The randomized, double-blind, placebo-controlled trial, conducted in the UK and Canada, aims to assess the efficacy, safety and tolerability of Haduvio. Its primary endpoint is the mean change in 24-hour cough frequency, measured using an objective cough monitor.

Participants are enrolled into two subgroups based on cough frequency: 10-19 coughs/hour and ≥20 coughs/hour. Secondary endpoints include patient-reported measures for cough frequency and severity. Approximately 60 adult patients are enrolled in the study. RCC, affecting 2-3 million US patients, currently has no approved therapies and causes significant social and economic impacts.