The FDA has approved Bevespi Aerosphere (glycopyrrolate/formoterol fumarate 9 mcg/4.8 mcg) for chronic obstructive pulmonary disease (COPD). The drug, developed by AstraZeneca, is the first long-acting muscarinic antagonist/long-acting beta-2 agonist combination in a pressurized metered-dose inhaler (pMDI).
Bevespi Aerosphere is indicated for the long-term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema.
The drug was approved based on data from the PINNACLE 1, PINNACLE 2, and PINNACLE 3 trials, which enrolled more than 3,700 patients with moderate to very severe COPD.
The trials showed that patients taking Bevespi Aerosphere had statistically significant improvements in morning pre-dose forced expiratory volume in 1 second at 24 weeks, compared with its mono-components and placebo. The drug also significantly improved peak forced expiratory volume in 1 second within 2 hours postdose and use of rescue medication.
The most common adverse reactions for patients taking Bevespi Aerosphere were urinary tract infection (2.6% vs 2.3% with placebo) and cough (4.0% vs 2.7% with placebo).
Bevespi Aerosphere is not indicated for the treatment of asthma or for acute bronchospasm relief.
The full prescribing information is available from the FDA: http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208294s000lbl.pdf.