Data from the Phase 2b CORAL trial of nalbuphine extended release (ER) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF) was recently published in the Journal of the American Medical Association (JAMA).
IPF is a rare, progressive disorder characterized by the progressive scarring of tissues in the lungs. Common symptoms include shortness of breath and a dry, hacking cough. In some cases fibrosis happens quickly, while in others, the process is slower. The cause of IPF is unknown. It is most often diagnosed in patients aged 60 to 70 years.
Nalbuphine extended release (ER), is a κ- opioid receptor agonist and μ-opioid receptor antagonist. It is currently indicated to manage moderate to severe pain when alternative options are ineffective.
The Phase 2b CORAL (NCT05964335) clinical trial was a double-blind, randomized, placebo-controlled, parallel-arm trial evaluating three doses of nalbuphine ER (27 mg, 54 mg, and 108 mg twice daily) compared to placebo for the treatment of chronic cough in patients with IPF over a 6-week treatment period.
A total of 165 patients with IPF chronic cough were randomized and 160 were included in the primary analysis. THe baseline mean cough count was 28.3 coughs per hour. In the nalbuphine ER 27 mg, 54, mg, and 108 mg twice-daily groups, the mean relative decrease in the cough count and the absolute decrease in coughs per hour were 47.9%, 53.4%, and 60.2%, respectively, compared with placebo.
For the key secondary outcome of patient-reported cough frequency at week 6, the relative and absolute changes were -31.4%, -40.6%, and -40.2% in the 27 mg, 54 mg, and 108 mg groups, respectively. This was compared with -21.9% in the placebo group.
Safety results were generally consistent with the known safety profile of nalbuphine ER from previous trials. Discontinuation rates due to adverse events were similar in the combined nalbuphine ER dose groups (5.6%) and placebo group (5.0%). The most common adverse events experienced included nausea, vomiting, constipation, dizziness, headache, fatigue, somnolence, and dry mouth. Serious adverse events were reported for four patients in the placebo group and for two patients treated with nalbuphine ER.
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To learn more about IPF and other rare lung conditions, visit https://checkrare.com/diseases/lung-diseases/