The US Food and Drug Administration has approved Striverdi Respimat (olodaterol) inhalation spray to treat patients with COPD, including chronic bronchitis and/or emphysema that are experiencing airflow obstruction, according to an agency press announcement. Striverdi Respimat, distributed by Boehringer Ingelheim Pharmaceuticals Inc, is designed to be used once daily over a long period of time, according to the FDA.
The drug 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 Striverdi Respimat was evaluated in 3,104 people diagnosed with COPD; people who received Striverdi Respimat showed improved lung function compared to placebo, according to the FDA.
“The availability of this new long-term maintenance medication provides an additional treatment options for the millions of Americans who suffer with COPD,” said Curtis Rosebraugh, MD., MPH, director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.
The drug carries a boxed warning that LABAs increase the risk of asthma-related death. The safety and effectiveness of Striverdi Respimat in people with asthma has not been established and it is not approved to treat asthma. Striverdi Respimat should not be used as a rescue therapy to treat sudden breathing problems (acute bronchospasm), the FDA noted.
In addition, Striverdi Respimat should not be used in patients with acutely deteriorating COPD and may cause serious side effects, including narrowing and obstruction of the respiratory airway (paradoxical bronchospasm) and cardiovascular effects, according to the agency.
The FDA approved Striverdi Respimat with a patient medication guide that includes instructions for use and information about the potential risks of taking the drug.
The most common side effects reported by people using Striverdi Respimat in the clinical study were nasopharyngitis (runny nose), upper respiratory tract infection, bronchitis, cough, urinary tract infection, dizziness, rash, diarrhea, back pain and arthralgia (joint pain).
More information is available on the FDA website.