FDA Approves Striverdi Respimat to Treat Chronic Obstructive Pulmonary Disease

The FDA approved a new inhalation spray called Striverdi Respimat to treat patients with chronic obstructive pulmonary disease (COPD).

In a latest announcement, the U.S. Food and Drug Administration approved Olodaterol (Striverdi Respimat), an inhalation spray that is meant to treat those with COPD including those with chronic bronchitis and/or emphysema that are experiencing airflow obstruction. The newly approved drug can be used daily over a long period of time.

Known as one of the serious lung diseases, COPD makes breathing difficult which gradually worsens over time. COPD causes symptoms like wheezing, cough, congestion in chest and shortness of breath. One of the leading causes of COPD is cigarette smoking. 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.

The newly approved drug is a long-acting beta-adrenergic agonist (LABA) that aids muscles around the airways in the lungs to stay relaxed so as to prevent symptoms. To test the safety and effectiveness of the drug, the researchers conducted a trial including 3,104 people diagnosed with COPD. They noticed that those who received the newly approved drug showed an improved lung function when compared to those receiving placebo.

Striverdi Respimat carries a boxed warning that LBASs increase the risk of asthma-related death. They safety and effectiveness of the drug in people with asthma has not been established and is not approved to treat asthma. The drug should not be used as a rescue therapy to treat sudden breathing problems.

The drug is also not meant for those with acutely deteriorating COPD; it may trigger side effects such as narrowing and obstruction of respiratory airway and cardiovascular effects.

The most common side effects are 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.