Nalbuphine ER for Idiopathic Pulmonary Fibrosis

(OCEAN-1 Trial)

This trial examines Nalbuphine ER to determine its effectiveness in reducing chronic cough in individuals with Idiopathic Pulmonary Fibrosis (IPF), a lung disease that causes scarring. The trial will assess the safety and efficacy of Nalbuphine ER by comparing it to a placebo (a treatment with no active drug). Participants with IPF who have experienced a chronic cough for at least 8 weeks and are on a stable dose of any antifibrotic medication may be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

If you are taking antifibrotic medication for IPF, you need to be on a stable dose for at least 6 weeks before starting the trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.

Previous research has shown that nalbuphine extended-release (NAL ER) is generally safe for people. Studies found no serious side effects. However, more than 25% of users reported minor issues such as nausea, tiredness, constipation, and dizziness. Despite these side effects, the treatment effectively reduced cough in patients with idiopathic pulmonary fibrosis (IPF). Higher doses led to better results in reducing cough. Overall, NAL ER appears well-tolerated, with benefits often outweighing the minor side effects.¹²³⁴⁵

Nalbuphine Extended-Release (NAL ER) is unique because it offers a fresh approach to treating Idiopathic Pulmonary Fibrosis (IPF) by potentially addressing pain management, which is often overlooked in current therapies. While standard treatments for IPF mainly focus on slowing disease progression with antifibrotic agents like pirfenidone and nintedanib, NAL ER introduces a new angle by utilizing an opioid receptor modulator to manage chronic discomfort associated with the condition. This novel mechanism of action could improve the quality of life for patients, making it an exciting development in the field of IPF treatment.

Research has shown that Nalbuphine Extended-Release (NAL ER) effectively reduces chronic cough in people with Idiopathic Pulmonary Fibrosis (IPF). One study found that patients taking NAL ER experienced a 76.1% decrease in cough frequency over a 24-hour period. Another study reported that 42% of patients using NAL ER experienced a 75% reduction in cough frequency, while none of the placebo group did. In this trial, participants will receive either NAL ER 54 mg or a placebo. Overall, patients taking higher doses of NAL ER experienced even greater reductions in coughing. This suggests that NAL ER could be very helpful in managing cough for people with IPF.²³⁵⁶⁷