Clinical-stage biopharmaceutical company Trevi Therapeutics Inc (Nasdaq:TRVI) announced on Thursday that key results from the Phase 2b CORAL trial of oral nalbuphine ER for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF) have been published in the Journal of the American Medical Association (JAMA).

Results showed a statistically-significant reduction in the relative change from baseline in 24-hour objective cough frequency observed across all dose groups of nalbuphine ER at Week 6 with statistically-significant cough reduction as early as Week 2, the first time point measured.

Over 60% of nalbuphine ER-treated patients achieved at least a 50% reduction in 24-hour cough frequency at Week 6 vs baseline.

Safety results were consistent with the known safety profile of nalbuphine ER from earlier trials, and discontinuation rates because of adverse events were similar in the combined nalbuphine ER dose groups (5.6%) and placebo group (5.0%).

James Cassella, PhD, Trevi Therapeutics' chief development officer, said: "The publication of these positive Phase 2b results with nalbuphine ER in JAMA represents an important validation of the trial findings and highlights the significance of chronic cough in patients with IPF. The statistically-significant reduction in 24-hour objective cough frequency across all dose groups shows the potential that nalbuphine ER has for the treatment of chronic cough in patients with IPF. We look forward to continuing the development of nalbuphine ER, and thank all the patients, investigators, and study staff, who have participated in our clinical trials to get us to this point."