FDA OKs Duaklir Fixed-Dose Combination Inhaler for COPD

Megan Brooks

April 01, 2019

The US Food and Drug Administration (FDA) has approved a fixed-dose combination of aclidinium bromide 400 μg and formoterol fumarate 12 μg (Duaklir, Circassia Pharmaceuticals) for the maintenance treatment of chronic obstructive pulmonary disease (COPD).

The combination is administered twice daily via the breath-actuated inhaler Pressair (AstraZeneca).

Aclidinium bromide is a long-acting muscarinic antagonist (LAMA) that acts primarily on the M3 receptor to relieve bronchospasm. Formoterol fumarate is a long-acting beta-agonist (LABA) that stimulates B2-receptors, resulting in bronchodilation.

Both aclidinium bromide and formoterol fumarate are separately approved for the maintenance treatment of COPD in the United States and Europe. Duaklir was approved by the European Medicines Agency for COPD in 2014.

The FDA approval of Duaklir was based on data from three phase 3 studies — ACLIFORM, AUGMENT, and AMPLIFY — which demonstrated significant improvements in lung function in patients with moderate to severe COPD, the company said.   

The Duaklir label also includes clinical data from the phase 4 ASCENT study, which showed aclidinium therapy reduces COPD exacerbations. "As a result, Duaklir is the only twice-daily LAMA/LABA in the United States with COPD exacerbation data included in its prescribing information," the company said.  

"With guidelines recommending combined LAMA and LABA therapy for a number of COPD patient groups, we believe Duaklir will make an important contribution to the treatment of this debilitating disease," Michael Asmus, Circassia's vice president for US medical affairs, said in the release.

The company said it is on track to launch Duaklir in the United States in the second half of 2019.

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