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FDA Approves Striverdi Respimat (Olodaterol) to Treat COPD
The FDA has approved once-daily Striverdi Respimat (olodaterol, Boehringer Ingelheim Pharmaceuticals) inhalation spray to treat patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, who are experiencing airflow obstruction.
COPD is a serious lung disease that makes breathing difficult and that worsens over time. Symptoms of the disorder include wheezing, cough, chest tightness, and shortness of breath. Cigarette smoking is the leading cause of COPD. According to the National Heart, Lung, and Blood Institute, COPD is the third leading cause of death in the U.S.
Olodaterol is a long-acting beta-adrenergic agonist (LABA) that helps the muscles around the airways in the lungs stay relaxed to prevent symptoms. The safety and effectiveness of oladaterol were evaluated in 3,104 subjects diagnosed with COPD. Subjects treated with oladaterol showed improved lung function compared with those given placebo.
The drug's labeling includes a boxed warning that LABAs increase the risk of asthma-related death. The safety and effectiveness of olodaterol in people with asthma have not been established, and it is not approved to treat asthma. The drug should not be used as a rescue therapy to treat acute bronchospasm.
Moreover, olodaterol should not be used in patients with acutely deteriorating COPD and may cause serious side effects in these patients, including paradoxical bronchospasm and cardiovascular effects.
The most common adverse effects associated with oladaterol in the clinical study included nasopharyngitis, upper respiratory tract infection, bronchitis, cough, urinary tract infection, dizziness, rash, diarrhea, back pain, and arthralgia.
Source: FDA; July 31, 2014.