Nalbuphine extended-release (ER) (Haduvio™), an investigational idiopathic pulmonary fibrosis (IPF) therapy, reduced the frequency of cough in a phase 2 clinical trial called CANAL. This finding is based on data from the full set of participants in the trial.
The results “are consistent with the previously announced interim analysis and further demonstrated that Haduvio has the potential to reduce IPF patients’ cough,” Jennifer Good, president and chief executive officer of Trevi Therapeutics, the developers of nalbuphine ER, said in a press release. “Consistent reductions” were observed in 24 hr cough frequency and daytime cough frequency, she said.
The aim of the double-blind, randomized, placebo-controlled, 2-treatment, 2-period crossover study was to investigate the safety and efficacy of nalbuphine ER in patients with IPF.
The study enrolled 42 participants in the United Kingdom and was completed on May 27, 2022. Its primary endpoint was the effect of the potential treatment on the mean daytime cough frequency compared to placebo.
The results showed that patients treated with nalbuphine ER had a statistically significant reduction in the frequency of daytime cough compared to those given a placebo.
Read more about the symptoms of IPF
The investigators reported 2 serious adverse events that occurred during the trial, but neither was considered to be related to nalbuphine ER. The most common adverse events were nausea, fatigue, constipation, dizziness, somnolence, vomiting, headache, anxiety, and depression.
Nalbuphine ER is an oral, extended-release, mixed ĸ-and µ-opioid receptor antagonist. ĸ-and µ-opioid receptors are known to mediate cough and itch. Nalbuphine injection has been approved and marketed in the United States for many years to treat pain.
IPF is a chronic progressive lung disease of unknown etiology, symptoms of which include dyspnea and chronic cough. There is currently no approved treatment for chronic cough in patients with IPF.
Trevi Therapeutics announces positive data from full set of subjects in phase 2 CANAL trial of Haduvio™ in the treatment of chronic cough in idiopathic pulmonary fibrosis. News release. Trevi Therapeutics, Inc; September 19, 2022.
A study of nalbuphine (extended release) ER in idiopathic pulmonary fibrosis (IPF) for treatment of cough (CANAL). ClinicalTrials.gov. July 23, 2019. Updated September 9, 2022. Accessed September 23, 2022.