Circassia Pharmaceuticals Inc. announced the launch of DUAKLIR® PRESSAIR® (aclidinium bromide and formoterol fumarate) for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).1 DUAKLIR will be available in the United States on October 21st and promoted through its dedicated COPD sales force, alongside established COPD treatment TUDORZA® (aclidinium), which is also administered twice-daily via PRESSAIR®. The US launch of DUAKLIR will happen simultaneously with the American College of Chest Physicians’ CHEST Annual Meeting 2019 in New Orleans, LA.
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.1 The product is approved worldwide, including in the European Union, under a number of brand names. Approval of DUAKLIR® 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.
COPD is a progressive disease associated mainly with tobacco smoking, air pollution or occupational exposure, which makes it hard to breathe and results in increased episodes of breathlessness.2,3 According to the American Lung Association, COPD is the third leading cause of death due to disease in the United States. More than 11 million people have been diagnosed with COPD, but millions more may have the disease without knowing it.4 COPD causes serious long-term disability and early death, and the number of people dying from COPD is growing.4
The most common symptoms of COPD are breathlessness (or a “need for air”), chronic cough, and sputum (mucus) production.3 Sufferers also frequently experience exacerbations, that is, serious episodes of increased breathlessness, cough and sputum production that last from several days to a few weeks. 3 These episodes can be seriously disabling and result in the need for urgent medical care (including hospitalization) and sometimes death.2
Please see complete Important Safety Information below and full prescribing information here.1
1 DUAKLIR® PRESSAIR® (aclidinium bromide/formoterol fumarate inhalation powder) [prescribing information]. Morrisville, NC: Circassia Pharmaceuticals Inc; 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210595lbl.pdf. Accessed March 29, 2019.
2 World Health Organization. Chronic Obstructive Pulmonary Disease (COPD) Fact Sheet. December 1, 2017. https://www.who.int/news-room/fact-sheets/detail/chronic-obstructive-pulmonary-disease-(copd) Accessed March 15, 2019.
3 Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. 2019.
4 American Lung Association. https://www.lung.org/lung-health-and-diseases/lung-disease-lookup/copd/learn-about-copd/how-serious-is-copd.html Accessed March 15, 2019.
5 Van der Palen J. et al. Preference, satisfaction and errors with two dry powder inhalers in patients with COPD. Expert Opin Drug Deliv 2013;10 (8):1023-1031.
6 Pascual S. et al. Preference, satisfaction and critical errors with GENUAIR and Breezhaler inhalers in patients with COPD: a randomised, cross-over, multicentre study. Primary Care Respiratory Medicine 2015; 25, 15018; doi:10.1038/npjpcrm.2015.18; Published online April 30 2015.
7 Gavaldà A. et al. Characterization of aclidinium bromide, a novel inhaled muscarinic antagonist, with long duration of action and a favorable pharmacological profile. J Pharmacol Exp Ther 2009;331:740-51.
8 Singh D. et al. Efficacy and safety of aclidinium bromide/formoterol fumarate fixed-dose combinations compared with individual components and placebo in patients with COPD (ACLIFORM-COPD): a multicentre, randomised study. BMC Pulmonary Medicine. 2014;14:178.
9 D’Urzo A. et al. Efficacy and safety of fixed-dose combinations of aclidinium bromide/formoterol fumarate: the 24-week, randomized, placebo-controlled AUGMENT COPD study. Respiratory Research. 2014;15:123.
10 Sethi S. et al. AMPLIFY: a randomized, Phase III study evaluating the efficacy and safety of aclidinium/formoterol vs monocomponents and tiotropium in patients with moderate-to-very severe symptomatic COPD. Int. J. COPD 2019:14 667—682. International Journal of COPD 14 2019 667 to 682. Accessed March 22, 2019.
11 Wise RA, Chapman KR, Scirica BM, et al. Effect of Aclidinium Bromide on Major Cardiovascular Events and Exacerbations in High-Risk Patients With Chronic Obstructive Pulmonary Disease: The ASCENT-COPD Randomized Clinical Trial. JAMA. 2019;321(17):1693-1701. doi:10.1001/ jama.2019.4973.
Source: Circassia Pharmaceuticals