Inhalation Spray Label Revised to Include New Data, Broader Indication

The FDA has approved new labeling for Boehringer Ingelheim's Stiolto Respimat (tiotropium bromide & olodaterol) Inhalation Spray that includes data showing a meaningful reduction in COPD exacerbations driven by tiotropium.

The FDA has approved new labeling for Boehringer Ingelheim's Stiolto Respimat (tiotropium bromide & olodaterol) Inhalation Spray that includes data showing a meaningful reduction in COPD exacerbations driven by tiotropium.

The agency also revised the indication for Stiolto Respimat to include approval for the treatment of patients with COPD, including chronic bronchitis and emphysema. Previously, the product's indication was for the treatment of airflow limitation in patients with COPD, including chronic bronchitis and emphysema. The revised language broadens the indication and illustrates that Stiolto Respimat does more than simply improve airflow, according to Boehringer Ingelheim.

The Stiolto Respimat label will be updated to include clinical trial data of Spiriva Respimat that shows a decrease in exacerbations, as well as data from the DYNAGITO trial, a 52-week study involving more than 7,800 people across a broad range of people living with COPD, comparing Stiolto Respimat to Spiriva Respimat in the reduction of COPD exacerbations.

“Also known as flare-ups, exacerbations are a serious complication from COPD that can further damage the lungs and make management of the disease more difficult,” said Antonio Anzueto, MD, a pulmonologist and professor of medicine at the University of Texas, Health, San Antonio, in a prepared statement. “When I’m treating my patients with COPD, it’s important to make sure I am taking steps to reduce their risk for an exacerbation, which could result in hospitalization or other serious complications.”

Symptoms of a COPD exacerbation may include increased breathlessness, cough, mucus production and extreme fatigue. Exacerbations can have a significant negative impact on people with COPD because they can cause permanent lung damage and possibly lead to lengthy hospitalizations or even death, according to Boehringer Ingelheim.

Stiolto Respimat should not be used by individuals with asthma, Boehringer Ingelheim said in a statement. According to the company, there is an increased risk of asthna-related death for patients with asthma who take long-acting beta2-agonist medicines, such as olodaterol, 1 of the medicines in Stiolto.

The most common adverse effects of the product are runny nose, cough and back pain.

References

Boehringer Ingelheim. FDA Approves Stiolto® Respimat® Supplemental New Drug Application (sNDA) to Add Data on COPD Exacerbation Reduction [news release]. Ridgefield, CT; October 11, 2018: Boehringer Ingelheim website. https://www.boehringer-ingelheim.us/press-release/fda-approves-stiolto-respimat-supplemental-new-drug-application-snda-add-data-copd?. Accessed October 12, 2018.