Boehringer Ingelheim announced that the Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Stiolto Respimat (tiotropium/olodaterol) that includes data demonstrating improvement in health-related quality of life among patients with chronic obstructive pulmonary disease (COPD) to the drug labeling.
OTEMTO 1 and 2 were Phase 3, 12-week, placebo-controlled trials that showed a clinically meaningful improvement in health-related quality of life, as measured by the St. George’s Respiratory Questionnaire (SGRQ), a disease-specific patient-reported instrument that evaluates symptoms, activities, and the impact of the disease on daily life. The labeling approval was also based on data from TONADO 1 and 2, which were Phase 3, 52-week active-controlled trials. The OTEMTO 1 and 2 and TONADO 1 and 2 are part of the TOviTO clinical program for Stiolto Respimat that included over 15,000 patients with varying degrees of COPD.
Stiolto Respimat, a combination of an anticholinergic and a long-acting beta-2 agonist (LABA), was approved in May 2015 for the long-term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema.
Stiolto Respimat is available as a 2.5mcg/2.5mcg strength per actuation and is supplied as a Respimat inhaler with a cartridge containing 60 inhalations.
For more information call (800) 542-6257 or visit Stiolto.com.