The Food and Drug Administration has given the nod to the first nebulized long-acting muscarinic antagonist (LAMA) treatment for chronic obstructive pulmonary disease (COPD) in the United States.
This product, 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, according to a statement from Sunovion Pharmaceuticals .
“Despite the availability of several therapies, many people still struggle to control their COPD – a challenge that may be affected by the delivery method used to administer a medication,” Gary Ferguson, MD , of Michigan State University and the Pulmonary Research Institute of Southeast Michigan, both in Farmington Hills, said in a statement. “Lonhala Magnair offers an important new option that combines the efficacy of a proven medication for COPD with the attributes of a unique, handheld nebulizer that allows a person to breathe normally while taking their medication.”
The approval of glycopyrrolate is based on the results of the GOLDEN (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer) trials. The GOLDEN program comprised the GOLDEN-3 and GOLDEN-4 trials, both of which were phase 3, 12-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter safety and efficacy trials, which compared adult glycopyrrolate patients to a placebo group with moderate to severe COPD. At 12 weeks, patients receiving treatment with glycopyrrolate showed clinical and statistically significant improvements in their baseline forced expiratory volume second (FEV1), compared with placebo.
GOLDEN-5 , an additional study, followed the same criteria as previous studies, but increased its length to 48 weeks to evaluate the long-term safety and patient tolerability of glycopyrrolate. It also compared treatment of COPD with glycopyrrolate to treatment of COPD with the previously approved LAMA Spiriva (tiotropium bromide), delivered by the Handihaler device. Glycopyrrolate was well tolerated, and the overall treatment emergence of adverse events for glycopyrrolate and tiotropium bromide were similar.
Sunovion expects glycopyrrolate to be available in U.S. pharmacies in early 2018, according to the statement.