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.