FDA approves tiotropium bromide mist for COPD

FDA approved tiotropium bromide (Spiriva Respimat) inhalation spray for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) and to reduce exacerbations in patients with COPD, according to a statement from Boehringer Ingelheim Pharmaceuticals.

With this approval of Spiriva Respimat, patients with COPD will be able to receive a pre-measured amount of tiotropium bromide, an anticholinergic, in a slow-moving mist, which may be easier to inhale than use of the Spiriva HandiHaler.

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COPD affects an estimated 24 million individuals in the United States, and approximately half of these people are not aware of their disease. It is important to identify COPD early before major loss of lung function, according to the COPD Foundation.

“Spiriva Respimat offers a new choice between a mist and dry powder inhaler for tiotropium,” said Sabine Luik, MD, senior vice president of Medicine and Regulatory Affairs, Boehringer Ingelheim. Spiriva Respimat has already been approved in 85 countries for patients with COPD.

The Spiriva Respimat approval was based on the results of seven clinical trials involving 8,700 patients who received the COPD therapy. The dose is two inhalations of the spray (2.5 µg each) once daily.

The most common side effects of drug were sore throat, cough, dry mouth, and sinus infection. It should not be used for acute use-as a rescue medication.

The manufacturer noted that the Respimat platform inhaler is the only inhaler in the United States that “uses mechanical energy to generate a slow-moving mist to deliver the medication,” the manufacturer stated.