The Food and Drug Administration has approved glycopyrrolate and formoterol fumarate inhalation aerosol for long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), according to a statement from AstraZeneca.

AstraZeneca is marketing the bronchodilator as Bevespi Aerosphere. The product is a fixed-dose dual bronchodilator delivered through a pressurized, metered-dose inhaler to be used twice daily. Glycopyrrolate, a long-acting muscarinic antagonist, is available as monotherapy. The FDA also has granted the long-acting beta-2 agonist formoterol fumarate tentative approval for use as monotherapy.

The approval of glycopyrrolate/formoterol fumarate 9 mcg/4.8 mcg is based on the PINNACLE trials, which demonstrated the product achieved improvement in morning predose forced expiratory volume in 1 second at 24 weeks (P less than .001), compared with its monotherapy components and placebo, according to AstraZeneca’s statement .

The most common adverse reactions were urinary tract infection and cough. The drug is not indicated for the treatment of asthma or for the relief of acute bronchospasm.