Circassia Pharmaceuticals Inc has launched Duaklir Pressair (aclidinium bromide and formoterol fumarate) for the maintenance treatment of patients with COPD. Duaklir was made available in the United States beginning on October 21st.
Duaklir Pressair is a fixed-dose LAMA/LABA combination of the long-acting muscarinic antagonist (LAMA) aclidinium and the long-acting beta agonist (LABA) formoterol. It is administered twice daily via the pre-loaded, breath-actuated, Pressair multi-dose inhaler.
The product is approved worldwide, including in the European Union, under a number of brand names. Approval of Duaklir Pressair is based on data from three Phase III studies, ACLIFORM, AUGMENT and AMPLIFY, and the Phase IV ASCENT-COPD study, which shows aclidinium therapy is effective at reducing exacerbations due to COPD.
David Acheson, SVP, US Commercial, said: “We have diligently built our COPD franchise through strong data and strong products. Today’s launch of Duaklir is the culmination of a strategic and concerted effort to help improve the lives of millions of Americans living with COPD. We are proud of the team at Circassia for working to achieve this important milestone, and are grateful to the researchers and patients for their contributions in helping to bring this important new COPD therapy to the US market.”
As part of Circassia’s launch activities, the Company hosted a Respiratory Educational Reception at the American College of Chest Physicians’ Chest Annual Meeting 2019. This Reception brought together posters presented at major scientific meetings in the US and Europe detailing results from the AMPLIFY and ASCENT-COPD studies. Circassia presentation at CHEST 2019 includes an Oral Presentation Session #4080 from 1:30-1:45 pm on Monday, October 21, in Room 292 of the Ernest N. Morial Convention Center, 900 Convention Center Blvd, New Orleans, LA 70130.
The complete safety information and full prescribing information is available here.