Highlights
The CORAL Phase 2b randomized clinical trial provides compelling evidence for the efficacy of nalbuphine extended release (ER) in treating idiopathic pulmonary fibrosis (IPF)-associated cough. Key highlights include:
- Dose-Dependent Reduction: All three tested doses of nalbuphine ER (27 mg, 54 mg, and 108 mg twice daily) met the primary endpoint, showing a significant relative reduction in 24-hour cough frequency compared to placebo.
- Objective Measurement: Using digital cough monitors, the study observed reductions in cough frequency ranging from 47.9% to 60.2% across the treatment arms.
- Symptom Improvement: The higher doses (54 mg and 108 mg) also demonstrated statistically significant improvements in patient-reported cough severity and frequency.
- Clinical Significance: These findings suggest nalbuphine ER could be a transformative therapy for a symptom that currently has no approved treatments and severely impacts quality of life.
