Slide 1: Analysis of Relief-of-Cough in Patients With IPF Treated With Oral Nalbuphine ER
Analysis of Relief-of-Cough in Patients With Idiopathic Pulmonary Fibrosis Treated With Oral Nalbuphine Extended Release
Slide 2: Alyn H. Morice, MD, FRCP
Alyn H. Morice, MD, FRCP Foundation Chair and Professor of Respiratory Medicine The University of Hull Hull, United Kingdom Co-authors: Kevin Carroll, PhD, and David Clark, MD
Slide 3: Financial Disclosure
Financial Disclosure Consulting fees from Bayer, Bellus Health Inc., Merck & Co. Inc., NeRRe Therapeutics, Shionogi Inc., and Trevi Therapeutics, Inc. Lecture fees from Boehringer Ingelheim, Chiesi Farmaceutici, and Merck & Co. Inc. Grant support from Bayer, Bellus Health Inc., Merck & Co Inc.
Slide 4: Background
Background Patients with idiopathic pulmonary fibrosis (IPF) have a high burden of disease, with significant impact on quality of life1,2 - ~85% of patients with IPF experience chronic cough,3 for which there are no approved therapies4 Nalbuphine extended release (NAL ER) is a neuromodulator tha
Slide 5: Objectives
Objectives Evaluate the effect of NAL ER on relief-of-cough duration in patients with IPF from the CANAL study To assess whether measuring cough severity, duration, and intensity could enhance communication between clinicians and patients IPF, idiopathic pulmonary fibrosis; NAL ER, nalbuphine extend
Slide 6: Methods
Methods CANAL: Randomized, Double-Blind, Placebo-Controlled, Phase 2a Crossover Trial Key Inclusion Criteria • ≥18 years of age • IPF diagnosis • Self-reported chronic cough lasting ≥8 weeks • Daytime CS-NRS ≥4 Key Exclusion Criteria • ILD from environmental exposure, connective tissue disease, or d
Slide 7: Results: Relief-Of-Cough Duration
Results NAL ER significantly increased relief-of-cough time, reduced cough time, and reduced cough intensity in patients with IPF compared with placebo NAL ER Placebo NAL ER Placebo 13.0% 0 30 Placebo-Adjusted Change Change From Baseline in Change From Baseline in 25 P = 0.0019 -10 Relief-Of-Cough
Slide 8: Conclusions
Conclusions These post hoc analyses of end points relevant to patient quality of life extend the primary outcomes of the CANAL trial1 In this study, treatment with NAL ER produced significantly greater relief-of-cough duration, reduced cough time, and reduced cough intensity compared with placeb
Slide 9: Thank You!
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