Nalbuphine ER Tablets found effective for Managing Cough In Idiopathic Pulmonary Fibrosis

A recent study published in The New England Journal Of Medicine has revealed encouraging findings regarding the use of nalbuphine extended-release tablets (NAL ER) as a potential treatment for cough in individuals with idiopathic pulmonary fibrosis (IPF). Led by Dr. Toby Maher from the Keck School of Medicine at the University of Southern California, the study highlighted the lack of approved cough therapies for this patient population.

IPF is a progressive lung disease characterized by scarring of lung tissue, leading to compromised lung function and respiratory symptoms. Persistent cough is one of the most common symptoms experienced by IPF patients.

The trial employed a randomized, double-blind, placebo-controlled crossover design, consisting of two 22-day treatment periods separated by a 2-week washout period. Patients received NAL ER, starting at an initial dose of 27 mg once daily, which was then increased to 162 mg twice daily by day 16.

The primary endpoint of the study was the percent change from baseline in hourly daytime objective cough frequency, as measured by an electronic cough monitor. Secondary endpoints included changes in objective 24-hour cough frequency, cough severity, and breathlessness based on patient-reported outcomes.

The analysis involved 41 IPF patients who were randomly assigned and received at least one dose of the study medication. Results showed a significant reduction in daytime objective cough frequency during the NAL ER treatment period, with a 75.1% decrease compared to a reduction of 22.6% observed during the placebo treatment period.

Researchers reported a placebo-adjusted change of 52.5 percentage points (P < 0.001) from baseline at day 21. In terms of 24-hour objective cough frequency, NAL ER demonstrated a 76.1% decrease, while the placebo group showed only a 25.3% decrease, resulting in a 50.8 percentage point placebo-adjusted change.

It should be noted that adverse events such as nausea, fatigue, constipation, and dizziness were more common in the NAL ER group compared to the placebo group. These findings emphasize the need to carefully evaluate the overall benefit-risk profile of NAL ER in IPF patients.

The trial results indicate promising potential for NAL ER in reducing cough frequency among individuals with IPF, addressing a significant unmet need for effective therapies targeting this clinical concern. Nevertheless, further research is warranted to evaluate the treatment's overall efficacy, tolerability, and clinical utility.

While the trial was not specifically designed to statistically test other outcomes, the data generated provide sufficient encouragement to warrant additional assessment in longer and larger clinical studies. Such trials will help determine the long-term effects of NAL ER on cough while considering potential adverse effects and loss of efficacy due to habituation associated with chronic opiate use, as noted by the investigators.

In conclusion, the promising results from this crossover trial highlight the potential of nalbuphine extended-release tablets as a viable option for reducing cough frequency in patients with idiopathic pulmonary fibrosis. Continued research will be crucial in establishing its efficacy, safety, and overall impact on the management of cough in IPF patients.

Reference:

Maher TM, Avram C, Bortey E, et al. Nalbuphine Tablets for Cough in Patients with Idiopathic Pulmonary Fibrosis. NEJM Evidence. 2023.