US COPD Coalition

Long-acting Nebulized Medication Receives FDA Approval


The U.S. Food & Drug Administration (FDA) has approved the long-acting muscarinic antagonist (LAMA) glycopyrrolate in nebulizer form for treatment of COPD. This is the first time a LAMA medication will be available via nebulizer. According to a recent article in Chest Physician, the online newspaper of the American College of Chest Physicians, nebulized glycopyrrolate “has specifically been approved for use as a long-term maintenance treatment of air-flow obstruction in patients with COPD. Glycopyrrolate (Lonhala Magnair) utilizes the eFlow technology system, developed by Pari Pharma. This nebulizing system is portable, virtually silent, and delivers the drug in 2-3 minutes.”

The FDA has approved nebulized glycopyrrolate based on the results of the GOLDEN (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer) clinical trials. Nebulized glycopyrrolate has shown to provide statistically and clinically significant improvements in FEV1 and the St. George’s Respiratory Questionnaire.