FDA approves Striverdi Respimat for COPD, includes asthma warning

The FDA has announced approval of olodaterol inhalation spray to treat patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema, who experience airflow obstruction.

Olodaterol (Striverdi Respimat, Boehringer Ingelheim Pharmaceuticals) is a long-acting beta-adrenergic agonist (LABA) that allows muscles around the lungs’ airways to stay relaxed to prevent symptoms and can be used daily for an extended period, according to an FDA press release. LABAs increase the risk for asthma-related deaths, according to Striverdi Respimat’s boxed warning.

“The safety and effectiveness of Striverdi Respimat in people with asthma has not been established, and it is not approved to treat asthma,” the release said. “Striverdi Respimat should not be used as a rescue therapy to treat sudden breathing problems (acute bronchospasm).”

People diagnosed with chronic obstructive pulmonary disease (COPD) who were treated with Striverdi Respimat in a clinical study displayed improved lung function compared with placebo. Reported side effects included nasopharyngitis, upper respiratory tract infection, bronchitis, cough, dizziness, rash, diarrhea, back pain and arthralgia.

“The availability of this new long-term maintenance provides an additional treatment option for millions of Americans who suffer with COPD,” Curtis Rosebraugh, MD, MPH, director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, said in the release.

Patients with acutely deteriorating COPD should not use Striverdi Respimat, according to the release. Serious side effects can include paradoxical bronchospasm and cardiovascular events.

Cigarette smoking is the leading cause of COPD, a lung disease that makes breathing progressively difficult, the release said. The disease is the No. 3 cause of death in the United States, according to the National Heart, Lung, and Blood Institute.