FDA Approves Olodaterol Inhalation Spray for COPD
The FDA approved a once-daily, long-term olodaterol inhalation spray (Striverdi Respimat, Boehringer Ingelheim Pharmaceuticals, Inc.) to treat patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema with airflow obstruction.
Striverdi Respimat is a long-acting, beta-adrenergic agonist (LABA) that relaxes the muscles around the airways to prevent symptoms of COPD—such as wheezing, cough, chest tightness, and shortness of breath.
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The most common side effects include runny nose, upper respiratory tract infection, bronchitis, cough, urinary tract infection, dizziness, rash, diarrhea, and back and joint pain.
A trial of 3104 people diagnosed with COPD shows that Striverdi Respimat improved lung function compared to placebo.
The safety and effectiveness of the drug in individuals with asthma has not been established and it is not approved to treat asthma. It should also not be used as rescue therapy to treat sudden breathing problems.
Note: Striverdi Respimat should not be used in patients with acutely deteriorating COPD and in these cases, might cause narrowing and obstruction of the respiratory airway and cardiovascular effects.
FDA. FDA approves Striverdi Respimat to treat chronic obstructive pulmonary disease [press release]. July 31, 2014. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm407465.htm. Accessed August 1, 2014.