Boehringer Ingelheim announced that the Food and Drug Administration (FDA) has approved Stiolto Respimat (tiotropium bromide and olodaterol) Inhalation Spray for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Stiolto Respimat combines tiotropium bromide, an anticholinergic, and olodaterol, a long-acting beta2-adrenergic agonist (LABA). Stiolto is administered via the Respimat Inhaler that delivers a slow-moving mist to help patients inhale the medication.
The FDA approval was based on Phase 3 TONADO 1 and 2 randomized, double-blind, active-controlled trials that evaluated over 5,000 patients with COPD. Study data showed it provided statistically significant improvements in lung function at 24 weeks vs. tiotropium and olodaterol alone.
Stiolto Respimat will be available as a 3.124mcg/2.736mcg (equivalent to 2.5mcg/2.5mcg) strength. It will be supplied as a carton containing one cartridge and one inhaler providing 60 metered actuations.
For more information call (800) 542-6257 or visit us.boehringer-ingelheim.com.