7/31/2014 3:05:58 PM
FDA Approves Striverdi Respimat To Treat Chronic Obstructive Pulmonary Disease
Today, the U.S. Food and Drug Administration approved Striverdi Respimat (olodaterol) inhalation spray to treat patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema that are experiencing airflow obstruction. Striverdi Respimat can be used once daily over a long period of time.
COPD is a serious lung disease that makes breathing difficult and worsens over time. Symptoms can 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 United States.
“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, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.
Striverdi Respimat 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.
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).
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.
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).
Striverdi Respimat is distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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