A Study of Nalbuphine (Extended Release) ER in Idiopathic Pulmonary Fibrosis (IPF) for Treatment of Cough

Phase 2 Completed 42 enrolled Trevi Therapeutics Parexel · collab

RandomizedCrossoverQuadruple-blindTreatment

Summary

To evaluate the safety and tolerability of nalbuphine ER tablets in the study population and to evaluate the effect of NAL ER tablets on the mean daytime cough frequency (coughs per hour) at Day 22 (dose 162 mg BID) as compared to placebo tablets.

Timeline

Start: 2019-10-29
Primary completion: 2022-05-27
Completion: 2022-05-27

Outcome

Met primary endpoint

registry analysis (superiority test); NAL ER vs Placebo; p < 0.0001; Geometric Mean Ratio 0.32 (95% CI 0.208 to 0.431) NCT04030026 ↗

paper There was a 75.1% reduction in daytime objective cough frequency during the NAL ER treatment period versus the placebo treatment period of 22.6% PMID 38320144 ↗

release “positive results from the Phase 2a CANAL trial, which demonstrated a statistically significant reduction in daytime cough frequency by 75.1%” trevitherapeutics.com ↗

Publications

Maher TM, Avram C, Bortey E, Hart SP, Hirani N, Molyneux PL, Porter JC, Smith JA, Sciascia T. Nalbuphine Tablets for Cough in Patients with Idiopathic Pulmonary Fibrosis. NEJM Evid. 2023 Aug;2(8):EVIDoa2300083. doi: 10.1056/EVIDoa2300083. Epub 2023 May 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nalbuphine	Small molecule	162 mg	—