(RxWiki News) A new therapy for people with chronic obstructive pulmonary disease, or COPD, has been approved by the U.S. Food and Drug Administration (FDA).
Arcapta Neohaler (indacaterol inhalation powder) is approved for long term, once-daily maintenance bronchodilator treatment of airflow obstruction in people with COPD.
Cigarette smoking is the leading cause of COPD, which is the fourth leading cause of death in the United States. Symptoms include chronic coughing, difficulty breathing and excessive phlegm.
Arcapta Neohaler works by relaxing muscles that surround airways in the lungs and eases wheezing and breathlessness.
Patients with COPD may be able to take a heavy sigh of relief with new inhaling powder treatment.
Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research, reports that the approval of the new long-term drug provides another treatment option for millions of people suffering with COPD.
Six clinical trials involving nearly 5,500 patients ages 40 and older, all of whom had a smoking history of at least one pack a day for 10 years and a clinical diagnosis of COPD, confirmed that Arcapta Neohaler was both safe and effective. Patients also exhibited moderate-to-severe decrease in lung function.
Arcapta Neohaler is a long-acting beta-2 adrenergic agonist (LABA) that can cause severe complications and an increased risk of death in patients with asthma. Arcapta Neohaler contains a warning pursuent to this risk.
The most common side effects of this newly approved COPD drug are coughing, sore throat, headaches, nausea and a runny nose.
