The FDA has added an asthma indication to Boehringer Ingelheim's tiotropium bromide inhalation spray (Spiriva Respimat).
The FDA has added an asthma indication to Boehringer Ingelheim’s tiotropium bromide inhalation spray (Spiriva Respimat).
This long-acting muscarinic antagonist (LAMA) was originally approved in September 2014 for the maintenance treatment of chronic obstructive pulmonary disease (COPD).
Two months later, the FDA started reviewing a regulatory submission to indicate Spiriva Respimat for the long-term, once-daily maintenance treatment of asthma in adults and adolescents, which it has since approved.
William Mezzanotte, head of respiratory medicine at Boehringer Ingelheim, stated that this approval "establishes a new class of inhaled asthma therapy and provides an efficacious, new option for patients.”
The medication’s asthma indication is based on clinical evidence that showed the treatment significantly improved lung function in patients aged 12 years or older with asthma who remained symptomatic on at least an inhaled corticosteroid (ICS).
For asthma, Spiriva Respimat is approved as a once-daily dose of 2.5 µg, delivered in 2 puffs of 1.25 µg each. For COPD, it is approved as a once-daily dose of 5 µg, delivered in 2 puffs of 2.5 µg each.
The most common side effects with Spiriva Respimat in patients with asthma are sore throat, sinus infection, bronchitis, and headache. It is not a treatment for sudden asthma symptoms.