FDA Clears Olodaterol (Striverdi Respimat) for COPD

Megan Brooks

Disclosures

July 31, 2014

The US Food and Drug Administration (FDA) has approved the long-acting beta-agonist, olodaterol (Striverdi Respimat, Boehringer Ingelheim), for long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

"The availability of this new long-term maintenance medication provides an additional treatment option for the 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 a statement.

In January 2013, the FDA's Pulmonary-Allergy Drugs Advisory Committee voted to recommend approval of olodaterol, as reported by Medscape Medical News .

In a study of 3104 patients with COPD, olodaterol was safe and improved lung function compared with placebo, the FDA notes.

The most common side effects in the clinical study were nasopharyngitis, upper respiratory tract infection, bronchitis, cough, urinary tract infection, dizziness, rash, diarrhea, back pain, and arthralgia.

Olodaterol carries a boxed warning that long-acting beta-agonists increase the risk for asthma-related death. The safety and effectiveness of olodaterol in people with asthma has not been established and it is not approved to treat asthma.

The FDA says olodaterol should not be used as a rescue therapy to treat acute bronchospasm. It should also 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 says.

Striverdi Respimat comes with a patient medication guide that includes instructions for use and information about the potential risks of taking the drug.

COPD is the third leading cause of death in the United States.

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