Glycopyrronium/Formoterol: A Review in COPD

Glycopyrronium/formoterol (Bevespi Aerosphere^®) is a fixed-dose combination of the long-acting muscarinic antagonist glycopyrronium bromide and the long-acting β₂-agonist formoterol fumarate delivered via a pressurized metered dose inhaler (pMDI) and formulated using co-suspension delivery technology. It is approved in the USA and EU for use as maintenance treatment in patients with chronic obstructive pulmonary disease (COPD) and in Japan to relieve symptoms in patients with COPD. In the PINNACLE trials in patients with moderate to very severe COPD, glycopyrronium/formoterol was associated with significantly greater improvements in lung function than its monocomponents and placebo at 24 weeks and its monocomponents and open-label tiotropium over 52 weeks. In the AERISTO trial, glycopyrronium/formoterol was non-inferior to umeclidinium/vilanterol dry powder inhaler for peak change in forced expiratory volume in 1 s (FEV₁) within 2 h postdose, but not for the change in morning predose trough FEV₁, over 24 weeks. Glycopyrronium/formoterol was generally well tolerated in patients with moderate to very severe COPD, with most adverse events (AEs) being of mild or moderate severity. Thus, glycopyrronium/formoterol pMDI formulated using co-suspension delivery technology is a useful new addition that extends treatment options for patients with COPD.