FDA Approves Breztri Aerosphere (budesonide/glycopyrrolate/formoterol) for COPD Maintenance

Budesonide is an inhaled corticosteroid (ICS) with anti-inflammatory activity. Glycopyrrolate is an anticholinergic that inhibits muscarinic receptors in bronchial smooth muscle, leading to bronchodilation. Formoterol fumarate is a long-acting beta2-adrenergic agonist (LABA) that relaxes bronchial smooth muscle.

Breztri Aerosphere is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Limitations of Use: Not indicated for relief of acute bronchospasm or for treatment of asthma.

For oral inhalation only. Recommended dosage: 2 inhalations of Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate 160 mcg/9 mcg/4.8 mcg per inhalation) twice daily (morning and evening). Do not exceed 2 inhalations twice daily. Rinse mouth with water after inhalation without swallowing. Prime before first use by releasing 4 sprays into the air, shaking well before each spray. If not used for more than 7 days, dropped, or after weekly rinsing, re-prime with 2 sprays.

Trial 1 (NCT02465567): 52-week, randomized, double-blind, multicenter, parallel-group trial in 8,588 subjects with moderate to very severe COPD and a history of 1+ moderate or severe exacerbations in the prior year. Subjects received Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate 320 mcg/18 mcg/9.6 mcg), glycopyrrolate/formoterol (GFF MDI 18 mcg/9.6 mcg), or budesonide/formoterol (BFF MDI 320 mcg/9.6 mcg) twice daily. Primary endpoint: rate of moderate or severe COPD exacerbations for Breztri Aerosphere vs GFF MDI and BFF MDI. Trial 2 (NCT02497001): 24-week trial in 1,896 subjects with similar design.

Not reported in label.

Breztri Aerosphere is a triple-combination maintenance therapy for COPD. It is not for acute bronchospasm or asthma. It may be considered for patients requiring ICS/LAMA/LABA combination therapy.