The US Food and Drug Administration announced the approval of a new drug for the treatment of chronic obstructive pulmonary disease.
The US Food and Drug Administration (FDA) announced the approval of a new drug for the treatment of chronic obstructive pulmonary disease (COPD).
Striverdi Respimat (olodaterol) is an inhaled medication that can be used by patients with COPD, including chronic bronchitis and/or emphysema, who are experiencing airflow obstruction, according to a statement from the FDA. The drug has been approved for once-daily use and can be used over a long period of time.
“The availability of this new long-term maintenance medication provides an additional treatment option for the millions of Americans who suffer from COPD,” noted Curtis Rosebraugh, MD, MPH, director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research in the statement.
A long-acting beta-adrenergic agonist (LABA), Striverdi Respimat is designed to help keep muscles around a patient’s airways relaxed in order to help control their symptoms. The drug was tested in a study that included 3,104 patients with COPD; those who were prescribed the drug showed more improvement in lung function than those who received a placebo.
Symptoms of COPD can include wheezing, coughing, chest tightness, and shortness of breath. According to the National Heart Lung and Blood Institute, COPD is the third-leading cause of death in the United States.
Striverdi Respimat carries a boxed warning that notes there is an increased risk of asthma-related death associated with the use of LABA medications. The FDA statement also noted the safety and effectiveness of Striverdi Respimat in patients with asthma has not been established and the medication is not currently approved to treat asthma. It also should not be used as a rescue therapy to treat acute bronchospasm.
The drug is also not recommended for patients with acutely deteriorating COPD as it may cause serious side effects, including narrowing and obstruction of the respiratory airway (paradoxical bronchospasm) and cardiovascular effects.
Side effects associated with Striverdi Respimat include runny nose, upper respiratory tract infection, bronchitis, cough, urinary tract infection, dizziness, rash, diarrhea, back pain, and joint pain.
The drug is distributed by Boehringer Ingelheim Pharmaceuticals, Inc. of Ridgefield, CT.