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Olodaterol LABA approved for some COPD patients


 

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The Food and Drug Administration approved olodaterol inhalation spray to treat airflow obstruction in patients with chronic obstructive pulmonary disease.

The drug (Striverdi Respimat, by Boehringer Ingelheim Pharmaceuticals) can be used once daily over a long period of time but should not be used as a rescue therapy to treat sudden breathing problems or in patients with acutely deteriorating chronic obstructive pulmonary disease (COPD), according to an FDA statement.

"This new long-term maintenance medication provides an additional treatment option for the millions of Americans who suffer with COPD," Dr. Curtis Rosebraugh of the FDA said in the statement.

Olodaterol is a long-acting beta-adrenergic agonist (LABA) that relaxes muscles around the lungs’ airways and helps them stay relaxed to prevent symptoms. In controlled, 48-week clinical trials in 3,104 patients with diagnosed COPD, investigators found improved lung function in those on olodaterol, compared with placebo.

The FDA’s approval included a boxed warning that LABA medications increase the risk of asthma-related death. Olodaterol is not approved to treat asthma, and the safety and effectiveness of the drug in people with asthma have not been established.

Serious side effects from olodaterol can include narrowing and obstruction of the respiratory airway (paradoxical bronchospasm) and cardiovascular effects. The most common side effects reported in clinical trials are runny nose, upper respiratory tract infection, bronchitis, cough, urinary tract infection, dizziness, rash, diarrhea, back pain, and arthralgia.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

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