Arcapta Inhaler Approved for COPD
TUESDAY July 5, 2011 -- The Arcapta Neohaler (indacaterol inhalation powder) has been approved by the U.S. Food and Drug Administration for the long-term treatment of chronic obstructive pulmonary disease (COPD).
COPD symptoms include airflow obstruction, breathlessness, chronic cough and excessive phlegm, the agency said in a news release. Cigarette smoking is a primary cause of COPD, which includes chronic bronchitis or emphysema.
Arcapta, among a class of drugs called beta2-adrenergic agonists, helps relax the lung's airways. It is not intended to treat asthma or the sudden, severe onset of breathing problems associated with COPD, the FDA said.
The inhaler was evaluated in a series of clinical studies involving nearly 5,500 people aged 40 and older who had been diagnosed with COPD. Participants all had smoked at least a pack of cigarettes per day for 10 years, and had demonstrated reduced lung function. The most common side effects reported were runny nose, cough, sore throat, headache and nausea.
The Arcapta Neohaler carries a boxed label warning that it increases the risk of asthma-related death. The product should not be used in people with asthma, unless used with a long-term asthma control medication, the FDA said.
The product is marketed by Novartis Pharmaceuticals, based in East Hanover, N.J.
To learn more about COPD, visit Medline Plus.
Posted: July 2011