The US Food and Drug Administration (FDA) approved a once-daily bronchodilator — indacaterol maleat for chronic obstructive pulmonary disease (COPD). This bronchodilator may offer better patient adherence than twice-a-day bronchodilators on the market.

Indacaterol maleate is a new molecular entity in the β₂-adrenergic agonist class that helps relax muscles around lung airways to prevent COPD symptoms, such as wheezing and breathlessness. The FDA stated that the long-acting drug is not intended to treat asthma or COPD symptoms that come on fast and strong.

Common adverse effects (> 2% and more common than placebo) are runny nose, cough, sore throat, headache, and nausea.

Indacaterol maleate will carry a boxed warning that, like other long-acting β₂-adrenergic agonists (LABAs), may increase the risk for asthma-related death.

Without use of a long-term asthma control medication, indacaterol maleate and all LABAs are contraindicated in patients with asthma. Indacaterol maleate should not be started in patients with acutely deteriorating COPD, nor should it be used to relieve acute symptoms, which should be managed with concomitant short-acting β₂-agonists.

An FDA advisory panel in March recommended approval of indacaterol maleate after 6 confirmatory clinical trials demonstrated the drug’s safety and efficacy. The trials included nearly 5500 patients 40 years and older with COPD who had smoked at least 1 pack of cigarettes for 10 years and exhibited moderate to severe decreases in lung function.

During the advisory panel meeting, John Walsh, the president of the nonprofit COPD Foundation, said that getting patients to faithfully take twice-daily LABAs is a challenge.

Clinical Use

• The FDA approved indacaterol maleate as a once-daily bronchodilator to prevent COPD symptoms, such as wheezing and breathlessness. Dosage is 75 μg inhaled once daily every day, which should increase compliance relative to twice-daily inhalers. It is not intended for acute relief of COPD exacerbations.
• Common adverse effects seen with use of indacaterol maleate are runny nose, cough, sore throat, headache, and nausea. It will carry a boxed warning that the risk for asthma-related death may be increased. There are several significant drug interactions.
• Indacaterol maleate is pregnancy Category C. It should be used during labor only in those patients in whom the benefits clearly outweigh the risks, and caution is warranted when indacaterol maleate is administered to breast-feeding women. Indacaterol maleate is not indicated for use in children. No adjustment of dosage is warranted in geriatric patients nor in patients with mild and moderate hepatic impairment.