Long-Acting COPD Treatment Gets FDA Approval
Glycopyrrolate inhalation solution is the first nebulized long-acting muscarinic antagonist for the treatment of chronic obstructive pulmonary disease.
The FDA has approved glycopyrrolate (Lonhala Magnair, Sunovion) inhalation solution, also known as SUN-101/eFlow, the first nebulized long-acting muscarinic antagonist (LAMA) for the treatment of chronic obstructive pulmonary disease (COPD).
Glycopyrrolate is indicated for the long-term maintenance treatment of airflow obstruction in people with COPD, including chronic bronchitis and/or emphysema, according to Sunovion. The approval also marks the first use of the Magnair, which is based on the closed EFlow technology system, developed by PARI Pharma GmbH, to treat COPD.
The approval is based on data from the clinical trials in the Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer (GOLDEN) program, which included GOLDEN-3 and GOLDEN-4. In the 12-week trials, glycopyrrolate was compared with placebo in adults with moderate to very severe COPD.
The GOLDEN-3 trial enrolled 653 individuals who were at least 40 years old, and the GOLDEN-4 trial enrolled 641 individuals who were at least 40 years old. Glycopyrrolate 25 mcg, glycopyrrolate 50 mcg, or a placebo was administered twice daily in both studies. Both studies included individuals who were taking effective background long-acting bronchodilator therapy and individuals with very severe disease and co-existing cardiovascular illness.
At week 12, participants treated with glycopyrrolate demonstrated statistically significant and clinically important changes from baseline in trough forced expiratory volume in 1 second (FEV1) versus placebo.
GOLDEN-5, an additional study, was a 48-week trial that evaluated the long-term safety and tolerability of glycopyrrolate in adults with moderate to very severe COPD, and included the active comparator tiotropium bromide (Spiriva) delivered by the HandiHaler device. The study enrolled 1087 individuals at 111 investigational sites in the United States and evaluated 50 mcg of glycopyrrolate delivered twice daily and active comparator 10 mcg of tiotropium bromide delivered once daily.
Overall, the treatment emergent adverse events incidences were similar for glycopyrrolate and tiotropium bromide over 48 weeks. The most common adverse events associated with glycopyrrolate were exacerbations and cough.
According to the statement, Sunovion expects glycopyrrolate to be available in US pharmacies in early 2018.
Sunovion receives FDA approval for Lonhala Magnair inhalation solution to treat COPD [news release]. Marlborough, MA: December 5, 2017. news.sunovion.com/press-release/sunovion-receives-fda-approval-lonhala-magnair-inhalation-solution-treat-copd. Accessed December 8, 2017.