Once-daily maintenance combo drug approved for COPD

June 1, 2015

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

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

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Stiolto is administered via Respimat, the platform inhaler for the Boehringer Ingelheim respiratory therapies, including approved and investigational therapies.

Stiolto Respimat is not indicated to treat asthma or acute deterioration of COPD. COPD, which includes chronic bronchitis and emphysema, is a serious but treatable lung disease. More than 15 million Americans have been told that they have COPD, but as many as 45% of the total estimated COPD cases in the United States remain undiagnosed. Patients are typically diagnosed when lung function is already significantly impaired. COPD symptoms can negatively impact a patient’s ability to breathe especially when performing daily activities.

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This combination therapy includes tiotropium, the active ingredient in Spiriva- the number 1 prescribed COPD maintenance therapy in the United States-and olodaterol, the active ingredient in Striverdi.

“We believe patients may appreciate the benefits of a maintenance medication that improves lung function within 5 minutes, lasts all day and reduces the use of rescue inhalers,” said Boehringer Ingelheim’s vice president of respiratory clinical development & medical affairs Danny McBryan, MD.

Respimat actively delivers a slow-moving mist that helps patients inhale the medication.

Stiolto Respimat significantly improved lung function compared with either drugs alone in clinical trials involving more than 5,000 patients according to the FDA. Nasopharyngitis, cough, and back pain were the most common adverse reactions reported.

Further, Stiolto Respimat is proven to be more effective than either Spiriva Respimat or olodaterol alone, with a comparable safety profile, according to Dr McBryan.