Once-Daily Striverdi Respimat Inhaler Approved for COPD
THURSDAY July 31, 2014, 2014 -- Striverdi Respimat (olodaterol) inhalation spray has been approved by the U.S. Food and Drug Administration to treat chronic obstructive pulmonary disease (COPD), the agency said Thursday in a news release.
COPD, which includes chronic bronchitis and chronic emphysema, is a progressive disease that makes breathing difficult by obstructing airflow through the lungs. Most commonly caused by smoking, it's the third-leading cause of death in the United States, the FDA said.
The once-daily inhaler relaxes lung airways, improving breathing. It was evaluated in a clinical study of more than 3,100 people diagnosed with COPD.
The drug's label will carry a boxed warning that it increases the risk of asthma-related death. The FDA said Striverdi Respimat hasn't been evaluated among people with asthma and is not approved to treat asthma or sudden breathing problems such as acute bronchospasm.
The product also shouldn't be used by people whose COPD is rapidly deteriorating, the agency warned.
Striverdi Respimat is distributed by Boehringer Ingelheim Pharmaceuticals, based in Ridgefield, Conn.
To learn more about this approval, visit the FDA.
Posted: July 2014