WASHINGTON -- The FDA has approved once-daily tiotropium bromide and olodaterol (Stiolto Respimat) inhalation spray for maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), the drug's maker announced Tuesday.
More than 15 million Americans have been told that they have COPD, but as many as 45% of the total estimated COPD cases in the U.S. remain undiagnosed, the manufacturer, Ridgefield, Conn.-based , noted in an email. Patients are typically diagnosed when lung function is already significantly impaired.
"While no treatment slows the rate of decline, maintenance treatment with Stiolto Respimat initiated at the time of diagnosis will improve lung function," Danny McBryan, MD, vice president for clinical development and medical affairs in the company's respiratory division, said in the email. The drug does not replace the use of a rescue inhaler.
Approval of Stiolto was based on two 52-week phase III randomized, double-blind, active-controlled trials involving more than 5,000 patients; the trials compared the drug with tiotropium 5 mcg alone and olodaterol 5 mcg alone. Researchers found that Stiolto provided statistically significant improvements in lung function -- as measured by trough FEV1 and FEV1 AUCo-3h -- compared with either drug alone, with a similar safety profile. Tiotropium is the active ingredient in Spiriva, another Boehringer drug for COPD, which was .
The Stiolto label will include a black-box warning noting that long-acting beta-2-adrenergic agonists such as olodaterol increase the risk of asthma-related death. Stiolto is not indicated for asthma and shouldn't be given to acutely deteriorating COPD patients, or to relieve acute symptoms, the company said.
Stiolto also may cause paradoxical bronchospasm that may be life-threatening; the most common adverse reactions were nasopharyngitis (seen in 12.4% of patients), cough (3.9%) and back pain (3.6%).
The drug may also cause hypersensitivity reactions, including urticaria, angioedema, rash, bronchospasm, anaphylaxis, or itching, to occur immediately after administration; if such a reaction does occur, the treatment should be discontinued immediately. Patients with a history of hypersensitivity reactions to atropine or its derivatives should be closely monitored for similar hypersensitivity reactions to Stiolto, Boehringer said.