FDA approves once-daily tiotropium with olodaterol (Stiolto)

Image: Stuart Fisher

The FDA approved Boehringer Ingelheim’s Stiolto, the latest of the new generation of once-daily inhalers for maintenance treatment of COPD. Stiolto contains the long-acting antimuscarinic agent tiotropium (Spiriva) and the long acting beta agonist olodaterol (marketed separately as Striverdi).

Stiolto made it to approval based on 2 separate year-long phase III randomized trials enrolling more than 5,000 patients. Typical of such studies, the drug was not compared with its competitors, but itself. One study tested Stiolto against tiotropium alone; the other was Stiolto vs olodaterol alone. The combination drug worked better than either drug alone at improving trough FEV1 and throughout the day.

Stiolto will reportedly be provided in a Respimat device, similar to Combivent in the U.S. and Spiriva Respimat in Europe.

Like other products containing long-acting beta agonists, Stiolto will carry a black-box warning on its package insert, for the possible risk of asthma-related death associated with LABAs.

Other warnings included bronchospasm (paradoxically); nasopharyngitis (in 1 of 8 patients treated); cough, back pain, and rare hypersensitivity reactions.