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FDA Approves Stiolto Respimat (Tiotropium/Olodaterol) as Once-Daily Maintenance Treatment for COPD
The FDA has given the nod to once-daily Stiolto (tiotropium bromide and olodaterol, Boehringer Ingelheim) inhalation spray delivered via the propellant-free Respimat inhaler. The product has been approved 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. Stiolto Respimat is not indicated for the treatment of asthma or acute deterioration of COPD.
Tiotropium is a long-acting anticholinergic and is the active ingredient in Boehringer’s Spiriva Respimat and Spiriva HandiHaler. Since its approval more than 10 years ago, Spiriva has extensive clinical experience involving more than 40 million patient-years and more than 200 clinical trials. Spiriva is the most-prescribed COPD maintenance treatment worldwide.
Olodaterol, marketed as Striverdi Respimat (Boehringer Ingelheim), is a long-acting beta-2 agonist that was specifically designed to complement the efficacy of Spiriva. Olodaterol has a rapid onset of action that results in improved airflow 5 minutes after the first dose.
The FDA’s approval of Stiolto Respimat was based on data from the pivotal phase III TONADO 1 and 2 trials, which evaluated more than 5,000 COPD patients and showed that tiotropium/olodaterol Respimat provides statistically significant improvements in lung function compared with tiotropium and olodaterol alone. The analyses found that tiotropium/olodaterol Respimat more than doubled the improvement in lung function compared with tiotropium Respimat in patients who had no prior maintenance bronchodilator therapy at baseline (148 mL vs. 72 mL, respectively). Moreover, tiotropium/olodaterol Respimat provided a significant improvement in lung function compared with tiotropium Respimat in patients across all COPD stages, with the greatest improvements seen in patients with early COPD.
The TONADO trials, part of the TOviTO clinical trial program involving more than 15,000 COPD patients worldwide, also showed that Stiolto Respimat has a safety profile similar to that of tiotropium or olodaterol alone.
COPD affects 210 million people worldwide and is predicted to become the third leading cause of death by 2030. Patients are typically diagnosed after lung function has been significantly impaired. The symptoms of COPD can negatively affect a patient’s ability to breathe, especially when performing daily activities.
Sources: Boehringer Ingelheim; May 26, 2015; and Boehringer Ingelheim; May 20, 2015.