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News From the Food and Drug Administration
June 7, 2016

Combination Treatment for COPD

Author Affiliations

Copyright 2016 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2016;315(21):2268. doi:10.1001/jama.2016.6562

The FDA has approved a fixed-dose dual bronchodilator that combines glycopyrrolate and formoterol fumarate in a pressurized, metered-dose inhaler. The drug, marketed as Bevespi Aerosphere, is indicated for long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) (http://1.usa.gov/1qVyi94).

Glycopyrrolate is a long-acting muscarinic antagonist (LAMA) while formoterol fumarate is a long-acting β2-agonist (LABA). Manufacturer AstraZeneca said in a statement that the combination medication is the first FDA-approved product using its unique technology that distributes drug crystals in a uniform suspension formed with porous, low-density phospholipid particles. The technology prevents the drug crystals from settling or intermingling, allowing consistent doses of different drugs to be dispensed from a single pressurized metered-dose inhaler (http://bit.ly/1VBpmTq).