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Revefenacin: A Once-Daily, Long-Acting Bronchodilator For Nebulized Treatment Of COPD

Authors Donohue JF, Mahler DA, Sethi S

Received 14 May 2019

Accepted for publication 23 September 2019

Published 19 December 2019 Volume 2019:14 Pages 2947—2958

DOI https://doi.org/10.2147/COPD.S157654

Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 3

Editor who approved publication: Dr Richard Russell


James F Donohue,1 Donald A Mahler,2,3 Sanjay Sethi4

1Pulmonary Medicine, UNC School of Medicine, Chapel Hill, NC, USA; 2Geisel School of Medicine at Dartmouth, Hanover, NH, USA; 3Director of Respiratory Services, Valley Regional Hospital, Claremont, NH, USA; 4University at Buffalo, State University of New York, Buffalo, NY, USA

Correspondence: James F Donohue
UNC School of Medicine, 4125 Bioinformatics Building CB#7020, Chapel Hill, NC 27599-0001, USA
Tel +1 984-974-5703
Fax +1 984-974-5737
Email James_Donohue@med.unc.edu

Abstract: Bronchodilation with muscarinic antagonists, β2-agonists, and inhaled corticosteroids remains the foundation of pharmaceutical treatment for patients with stable COPD. These drugs are delivered from a variety of devices, including dry powder inhalers, pressurized metered-dose inhalers, soft-mist inhalers, or nebulizers. Nebulized delivery is often preferable in patients who are elderly, are cognitively impaired, are unable to generate sufficient inspiratory force to use their inhaler, have difficulty coordinating hand-breath activity, are too dyspneic to hold their breath for a sufficient time, and/or may be acutely ill. Revefenacin, a once-daily long-acting muscarinic antagonist for nebulization recently approved by the US FDA for the treatment of patients with COPD, was discovered and developed using “duration and lung selectivity-by-design.” This strategy selected a molecule with a high lung-selective index to maximize bronchodilation and limit systemic anti-muscarinic side effects. In early-phase clinical studies, revefenacin for nebulization led to a rapid onset of bronchodilation that was sustained for 24 hrs in patients with moderate to severe COPD. Revefenacin also demonstrated minimal systemic exposure and good tolerability in these studies. Statistically and clinically significant improvements in lung function (ie, peak and/or trough FEV1) relative to placebo were observed with revefenacin in Phase III clinical trials of up to 3 months in patients with moderate to very severe COPD. Revefenacin was well tolerated in Phase III clinical trials with a low incidence of systemic antimuscarinic adverse events, which is consistent with its lung-selective design. There was no evidence of an increased risk of major cardiovascular events. Patient-reported outcome data from clinical trials indicated statistically significant improvements in several disease-specific measures. Revefenacin 175 μg for nebulization provides an effective once-daily treatment option for patients with moderate to very severe COPD who require or prefer nebulized therapy.

Keywords: long-acting muscarinic antagonist, LAMA, bronchodilator, inhaled, once daily, nebulizer

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