Stiolto™ Respimat® (tiotropium bromide and olodaterol) Receives FDA Approval for COPD
Boehringer Ingelheim announced that the FDA approved StioltoTM Respimat® for the long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Stiolto Inhalation Spray is a combination of tiotropium, an anticholinergic, and olodaterol, a long-acting beta2-adrenergic agonist.
Stiolto Respimat is administered via Respimat inhaler, which delivers a slow-moving mist, allowing patients to safely and properly inhale the medication. The duration of inhalation should be at least 1.5 seconds—the length of the spray duration.
The trials evaluated more than 5000 COPD patients and demonstrated how tiotropium bromide and olodaterol provided statistically significant improvements in lung function at 24 weeks versus tiotropium and olodaterol alone. The 52-week Phase 3 trials were randomized, double-blind, active-controlled trials that compared Stiolto Respimat to tiotropium Respimat 5 mcg and olodaterol Respimat 5 mcg. Both trials were part of the TOviTO® clinical trial program involving more than 15,000 COPD patients worldwide.
The most common adverse reactions with STIOLTO (>3% incidence and higher than any of the comparators – tiotropium and/or olodaterol) were: nasopharyngitis, 12.4% (11.7%/12.6%), cough, 3.9% (4.4%/3.0%), and back pain, 3.6% (1.8%/3.4%).
