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The Food and Drug Administration has approved a fixed-dose triple inhaler containing budesonide/glycopyrrolate/formoterol fumarate for maintenance treatment of asthma in patients aged 12 years and older, according to the manufacturer in a press release. The single-inhaler regimen combines a corticosteroid and a long-acting beta2-agonist with a long-acting muscarinic antagonist. The inhaler is intended for asthma patients not adequately controlled on dual therapy. Approval was based on phase III trials, which showed statistically significant improvements in lung function with measurable bronchodilation within 5 minutes of the first dose. This is a new indication for the inhaler, which is used as maintenance therapy rather than for acute asthma symptom relief.Â
Better asthma control: Manufacturer AstraZeneca notes the inhaler’s new indication is an option to help reduce exacerbations in patients with persistent symptoms despite standard therapy. The inhaler was previously approved for chronic obstructive pulmonary disease, making asthma its second indication. Full prescribing information for clinicians is available on the product website.