Nalbuphine extended-release (Haduvio) reduces coughing in a highly statistically significant manner in patients with idiopathic pulmonary fibrosis (IPF), according to interim results from a phase 2 clinical trial called CANAL.

Based on these results, the trial will stop recruiting new participants, and Trevi Therapeutics, the developers of the treatment will accelerate development.

“We are excited about the clinically and highly statistically significant results of Haduvio in the CANAL trial and the potential to treat chronic cough in IPF patients,” Bill Forbes, MD, chief development officer at Trevi Therapeutics said in a press release from the company.


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Chronic cough is a serious complication of terminal disease in patients with IPF that has a negative impact on their physical, emotional, and psychological wellbeing. However, there are no approved therapies to treat chronic cough in these patients, and antifibrotics do not usually alleviate this symptom.

“These are extremely encouraging results that show the potential of nalbuphine [extended-release] to significantly improve the debilitating chronic cough which often severely impacts quality-of-life in many patients with IPF,” said Toby Maher, MD, Professor of Clinical Medicine and director of Interstitial Lung Disease at Keck School of Medicine of the University of Southern California in Los Angeles.

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Nalbuphine extended-release is an investigational therapy consisting of ĸ-opioid receptor agonist and µ-opioid receptor antagonist. The ĸ- and µ-opioid receptors are key mediators of cough. Since nalbuphine extended-release blocks µ-opioid receptors, the risk of abuse may be low.

CANAL is a double-blind, randomized, placebo-controlled, 2-treatment, 2-period crossover study that assesses the safety and efficacy of nalbuphine extended-release in treating cough in patients with IPF.

Based on interim data from the trial, Trevi conducted a statistical analysis assessing the trial’s probability of success, which showed a 100% success rate. The interim analysis was conducted on 26 patients and showed statistical significance on the primary efficacy endpoint, showing a 52% placebo-adjusted reduction in daytime cough events in patients treated with nalbuphine extended-release.

References

Trevi Therapeutics reports statistically significant result(s) on interim analysis from the Ph2 CANAL trial of nalbuphine ER in the treatment of chronic cough in idiopathic pulmonary fibrosis. News release. Trevi Therapeutics; February 24, 2022.

A study of nalbuphine (extended release) ER in idiopathic pulmonary fibrosis (IPF) for treatment of cough (CANAL). US National Library of Medicine. Updated December 8, 2021. Accessed February 28, 2022.