TUESDAY, July 5 (HealthDay News) -- 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).
Arcepta, a beta2-adrenergic agonist, 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 in a news release.
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 Arcepta 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.
More information
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