Circassia announced that the Food and Drug Administration (FDA) has approved Duaklir Pressair (aclidinium bromide, formoterol fumarate) for the maintenance treatment of chronic obstructive pulmonary disease (COPD).

Duaklir Pressair combines aclidinium bromide, a long-acting muscarinic antagonist (LAMA), and formoterol fumarate, a long-acting beta2-adrenergic agonist (LABA). It is intended for twice-daily use with the breath-actuated Pressair inhaler.

The approval was supported by data from the phase 3 ACLIFORM, AUGMENT, and AMPLIFY studies which included patients with moderate to very severe COPD. The 24-week trials evaluated the efficacy of Duaklir Pressair compared with aclidinium 400mcg, or formoterol fumarate 12mcg in nearly 5000 patients aged >40 years.

Results showed that treatment with Duaklir Pressair led to a statistically significant increase in mean change from baseline in trough FEV1 and change from baseline in 1-hour post-dose FEV1 at week 24 (co-primary endpoints) relative to formoterol fumarate 12mcg and aclidinium 400mcg, respectively.

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In addition, the labeling includes results from the phase 4 ASCENT study (N=3630) which evaluated aclidinium bromide in patients with moderate to very severe COPD with and without a history of exacerbations. The primary endpoint was rate of moderate to severe exacerbations during the first year of treatment, defined as worsening of COPD symptoms for at least 2 consecutive days that required treatment with antibiotics and/or systemic corticosteroids or resulted in hospitalization or death. The data showed aclidinium bromide statistically significantly reduced COPD exacerbations by 17% vs placebo (P=.003).

“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,” stated Michael Asmus, Circassia’s Vice President, US Medical Affairs.

Duaklir is anticipated to launch in the second half of this year as a 400mcg/12mcg strength dry powder inhaler containing 30- or 60-metered doses.

For more information call (800) 236-9933 or visit Circassia.com.