Nalbuphine Extended-Release Reduces Chronic Cough in IPF, with Philip Molyneaux, MBBS

Published on: October 24, 2025

Conference | American College of Chest Physicians

Nalbuphine extended-release significantly reduced objective measures of cough frequency among patients with idiopathic pulmonary fibrosis (IPF) and chronic cough, according to phase 2B trial data presented during late-breaking sessions at the American College of Chest Physicians (CHEST) 2025 Annual Meeting in Chicago, IL, this week.1

The new trial data, presented by Philip Molyneaux, MBBS, professor of interstitial lung disease at Imperial College London, additionally showed patients who received the 2 highest assessed doses of the dual-acting oral agent reported significantly improved health-related quality of life (HRQoL) versus placebo at 6 weeks.

The findings add evidence to the cough-related benefit of nalbuphine extended-release — which additionally at CHEST 2025 was reported to significantly improve refractory chronic cough severity and frequency in phase 2A trial data.2

In an interview with HCPLive during CHEST 2025, Molyneaux shared his biggest takeaways from the assessment — including the approximate 60% reduction in 24-hour objective cough frequency among patients receiving the highest assessed dose (108 mg twice daily). That finding, paired with measures of patient perspective on their health, provided an encouraging mid-phase trial result.

“The objective cough count — the primary outcome — was positive, but the secondaries were also positive,” Molyneaux said. “Patient perception of how often they coughed went down, patient perception of how severe their cough was improved, and patient quality of life improved over the study as well.”

Regarding the unique approach to treating patients with IPF and chronic cough with nalbuphine, Molyneaux emphasized the physiology of the uncommon respiratory disease: patients’ lungs are smaller, scarred, less elastic.

“Given the architectural abnormalities in the lungs and the differences in the physiology, the fact that this has got central and peripheral mechanism of action is important, and I think that's why we're seeing such big reductions in cough counts — the mechanism of action itself, the pathway,” Molyneaux said.

On average, the patients assessed in the trial had chronic cough for ≥4 years — a common initial symptom among patients newly diagnosed with IPF (approximately 85%). These data support the notion that nalbuphine extended-release may be an immediate and long-term treatment option for relevant patients — not something considered for late-stage disease.

“If in the later-phase studies, all these results are borne out — if we get a drug that can help patients and treat their cough — we're going to be able to tell them, ‘We're can impact your symptoms from a day-to-day basis. We're going to be able to improve upon your quality of life.’ So, it will go hand-in-hand with the anti-fibrotic treatment.”

References

Molyneaux P, Mogulkoc NM, Gunen BH, Doboszynska A, et al. Baseline Type 2 Biomarkers as Predictors of Multicomponent Clinical Remission Following Dupilumab Treatment in Patients with Moderate-To-Severe Asthma. Poster presented at: CHEST Annual Meeting 2025. Chicago, IL. October 19 – 22, 2025.
Satia I. Extended-Release Nalbuphine Improves Patient-Reported Refractory Chronic Cough Within 1 Week. HCPLive. Published online October 21, 2025. https://www.hcplive.com/view/extended-release-nalbuphine-improves-patient-reported-refractory-chronic-cough-1-week

Nalbuphine Extended-Release Reduces Chronic Cough in IPF, with Philip Molyneaux, MBBS

What measures did patients receiving nalbuphine extended-release significantly improve in?