Arcapta Inhaler Approved for COPD07/05/11
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).
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.
Arcepta, 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 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.
To learn more about
COPD, visit Medline Plus.
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