FDA approves Striverdi Respimat to treat COPD

August 4, 2014

FDA has approved olodaterol (Striverdi Respimat, Boehringer Ingelheim) Inhalation Spray 5 µg as a long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

FDA has approved olodaterol (Striverdi Respimat, Boehringer Ingelheim) Inhalation Spray 5 µg as a long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Striverdi Respimat is not indicated to treat acute deteriorations of COPD and is not indicated to treat asthma.

Striverdi Respimat is a long-acting beta-adrenergic agonist (LABA) that helps the muscles around the airways in the lungs stay relaxed to prevent symptoms.

“Despite the advances made in recent years in the treatment of COPD, the need remains for additional therapies,” said Tunde Otulana, MD, senior vice president, clinical development and medical affairs at Boehringer Ingelheim. “Patients and physicians are always looking for new treatment options, and it will benefit the COPD community to have new options for maintenance treatment of COPD.”

According to Dr Otulana, many COPD patients in clinical practice are likely to be on more than 1 therapy to treat airflow obstruction.

In an effort to more accurately represent the clinical practice setting, patients involved in the 48-week studies were allowed to continue on their usual care with the exception of LABAs. Usual care included long- and short-acting anticholinergics, short-acting beta agonists, inhaled corticosteroids and xanthines.  

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

It should not be used in patients with acutely deteriorating COPD and may cause serious side effects, including narrowing and obstruction of the respiratory airway and cardiovascular effects.

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

Nasopharyngitis (runny nose), upper respiratory tract infection, bronchitis, cough, urinary tract infection, dizziness, rash, diarrhea, back pain and arthralgia were the most common side effects reported by people using Striverdi Respimat in the clinical study.