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US Food and Drug Administration Approves DUAKLIR® PRESSAIR® (aclidinium/formoterol) for Patients with Chronic Obstructive Pulmonary Disease (COPD)

06:55 EDT 17 Apr 2019 | Businesswire

Circassia Pharmaceuticals Inc.

Only twice-daily LAMA /LABA in the United States with COPD exacerbation data included in its prescribing information

Circassia Pharmaceuticals Inc. (“Circassia” or “the Company”), today announced that the US Food and Drug Administration has approved DUAKLIR® PRESSAIR®(aclidinium bromide and formoterol fumarate) for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).1

DUAKLIR PRESSAIRis 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.

In April 2017, Circassia and AstraZeneca established a commercial collaboration in the United States under which Circassia has exclusive US commercialization rights to DUAKLIR PRESSAIRand AstraZeneca is responsible for the product’s development and regulatory submission.

“Our collaboration with AstraZeneca throughout the DUAKLIR PRESSAIR regulatory process has been overwhelmingly positive,” said David Acheson, Senior Vice President, US Commercial, Circassia. “We look forward to bringing DUAKLIR PRESSAIRto market in the coming months as an important expansion of Circassia’s COPD and respiratory health portfolio.”

“The FDA approval of DUAKLIR PRESSAIRgives COPD patients a new, effective and safe option in LAMA/LABA therapy, enabling them to receive maximal improvement in lung function delivered through a unique dry-powder inhaler,” said Michael Asmus, Vice President, US Medical Affairs, Circassia.

COPD (chronic obstructive pulmonary disease) 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 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

About the PRESSAIR® Inhaler

DUAKLIR® is administered via the PRESSAIR® Inhaler.1 The PRESSAIR® inhaler has shown to be preferred by patients when compared to other inhaler devices commonly used for COPD.5,6 PRESSAIR® is a multi-dose dry powder inhaler (DPI) that combines two positive feedback mechanisms, and is pre-filled with the DUAKLIR® treatment, which relaxes the muscles of the airways, helping to keep them open, allowing the patient to breathe more easily.1,7

About DUAKLIR® PRESSAIR® Phase-III AMPLIFY Clinical Trial

The FDA approval of DUAKLIR PRESSAIRis based on data from several studies including ACLIFORM,8 AUGMENT,9 and the recently-published AMPLIFY clinical trial.10

The findings of the AMPLIFY trial (NCT02796677) were published online March 22, 2019 in the International Journal of COPD originally published by Dove Medical Press Ltd International Journal of COPD 14 2019 667 to 682.10 This phase III clinical trial compared the efficacy and safety of inhaled DUAKLIR® PRESSAIR® to its individual components aclidinium and formoterol, and to inhaled Spiriva® Handihaler® (tiotropium) in 1,583 patients with moderate-to-very-severe symptomatic (COPD). The trial found that:

  • DUAKLIR PRESSAIRsignificantly improved lung function versus aclidinium as measured by the change from baseline at 24-weeks in the forced expiratory volume in one second (FEV1) one-hour post-dose
  • DUAKLIR PRESSAIRsignificantly increased lung function versus formoterol measured by change from baseline in pre-dose morning (trough) FEV1 at week 24
  • Overall nighttime and early-morning symptom severity scores (as measured by NiSCI and EMSCI questionnaires) showed numerical improvements with DUAKLIR PRESSAIRcompared to aclidinium or formoterol over 24 weeks and significant improvements in overall early-morning symptom severity score versus Spiriva® Handihaler® (tiotropium)
  • A pre-planned sub-study of AMPLIFY in 566 patients measuring lung function over 24-hours demonstrated DUAKLIR PRESSAIRsignificantly improved lung function at 24-weeks versus Spiriva® (tiotropium) as measured by average area under the curve for FEV1 obtained from 0 through 24 hours.

“The results of the AMPLIFY trial showed us that the benefits of the combination were more than its individual components in terms of efficacy, with a comparable safety profile,” said Sanjay Sethi, MD, Professor and Chief, Pulmonary, Critical Care and Sleep Medicine, Jacobs School of Medicine & Biomedical Sciences, University at Buffalo, and investigator on the AMPLIFY trial. “The study also showed a reduction in the use of rescue inhalers in the DUAKLIR PRESSAIR group, which is a good measure of symptom control in symptomatic COPD patients. DUAKLIR PRESSAIR will be a welcome addition to the armamentarium to help these patients.”

The proportion of patients reporting treatment-related adverse event (AE) was similar between treatment groups in AMPLIFY.10 The most common adverse events reported in the AMPLIFY10 study were COPD exacerbations (18.3%), nasopharyngitis (11.8%) and headache (4.9%). The incidence of serious AEs (7.8%), major adverse cardiovascular events (0.7%), and AEs leading to discontinuation (7.1%) or death (0.5%) was very low in AMPLIFY and similar across treatment groups.10

About Circassia Pharmaceuticals Inc.

Circassia Pharmaceuticals Inc. is part of the Circassia Pharmaceuticals plc group. Circassia is a world-class specialty pharmaceutical business focused on respiratory disease. Circassia sells its novel, market-leading NIOX® asthma management products directly to specialists in the United States, United Kingdom, China and Germany, and in a wide range of other countries through its network of partners. In the United States, Circassia has a commercial collaboration with AstraZeneca in which it has the commercial rights to chronic obstructive pulmonary disease (COPD) treatments TUDORZA PRESSAIR and DUAKLIR® PRESSAIR®. Circassia also has the commercial rights to the late-state ventilator-compatible nitric oxide product AirNOvent in the United States and China. For more information please visit www.circassia.com, or follow us on Twitter @CircassiaUSA and LinkedIn.

Indication and Usage

DUAKLIR PRESSAIR (aclidinium bromide/formoterol fumarate inhalation powder) is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

Important Safety Information

  • DUAKLIR PRESSAIR(aclidinium bromide/formoterol fumarate inhalation powder) is only indicated for use in COPD and is not indicated for use in asthma. Use of a long-acting beta2-adrenergic agonist (LABA) as monotherapy, including formoterol fumarate, one of the active ingredients in DUAKLIR PRESSAIR, without an inhaled corticosteroid (ICS) is contraindicated in patients with asthma and increases the risk of asthma-related death. When LABA are used in fixed-dose combinations with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared to ICS alone.
  • DUAKLIR PRESSAIR is contraindicated in patients with severe hypersensitivity to milk proteins or who have hypersensitivity to aclidinium bromide or formoterol fumarate or any component of the product
  • DUAKLIR PRESSAIR is not indicated for the treatment of acute episodes of bronchospasm (i.e. rescue therapy)
  • Do not initiate DUAKLIR PRESSAIR with an additional medicine containing a LABA because of risk of overdose or in acutely deteriorating COPD
  • Immediate hypersensitivity reactions, including anaphylaxis, angioedema (swelling of lips, tongue, or throat), urticaria, rash, bronchospasm, or itching have occurred after administration of DUAKLIR PRESSAIR. Additionally, inhaled medicines, including DUAKLIR PRESSAIR, may cause paradoxical bronchospasm which may be life threatening. If any of these occurs, immediate treatment with a short acting bronchodilator should be initiated and treatment with DUAKLIR PRESSAIR should be stopped and alternative therapy initiated
  • DUAKLIR PRESSAIR should be used with caution in patients with cardiovascular and convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, hypokalemia, hyperglycemia, narrow-angle glaucoma or urinary retention. Instruct patients to consult a physician immediately should any signs or symptoms of acute narrow-angle glaucoma or prostatic hyperplasia or bladder-neck obstruction develop
  • The most common adverse reactions (≥3% incidence and more common than placebo) were upper respiratory tract infection (8.9% vs 6.3%), headache (6.3% vs 5.1%), and back pain (3.8% vs 3.4%) for DUAKLIR PRESSAIR vs placebo, respectively. Other adverse reactions reported in clinical studies (>1% but less than 3% and more common than placebo) with DUAKLIR PRESSAIR were cough, sinusitis, influenza, tooth abscess, insomnia, dizziness, dry mouth, oropharyngeal pain, muscle spasm, musculoskeletal pain, arthralgia, pain in extremity, urinary tract infection, and increased blood creatine phosphokinase

Full prescribing information can be found at www.Duaklir.com.

You are encouraged to report negative side effects of prescription drugs to the FDA www.FDA.gov/medwatch or call 1-800-FDA-1088.

Forward-looking statements

This press release contains certain projections and other forward-looking statements with respect to the financial condition, results of operations, businesses and prospects of Circassia. The use of terms such as “may”, “will”, “should”, “expect”, “anticipate”, “project”, “estimate”, “intend”, “continue”, “target” or “believe” and similar expressions (or the negatives thereof) are generally intended to identify forward-looking statements. These statements are based on current expectations and involve risk and uncertainty because they relate to events and depend upon circumstances that may or may not occur in the future. There are a number of factors that could cause actual results or developments to differ materially from those expressed or implied by these forward-looking statements. Any of the assumptions underlying these forward-looking statements could prove inaccurate or incorrect and therefore any results contemplated in the forward-looking statements may not actually be achieved. Nothing contained in this press release should be construed as a profit forecast or profit estimate. Investors or other recipients are cautioned not to place undue reliance on any forward-looking statements contained herein. Circassia undertakes no obligation to update or revise (publicly or otherwise) any forward-looking statement, whether as a result of new information, future events or other circumstances.

Aclidinium bromide/formoterol fumarate is marketed under a number of brand names around the world, including DUAKLIR® Genuair® and Brimica® Genuair®.

References:

1 DUAKLIR® PRESSAIR® (aclidinium bromide/formoterol fumarate inhalation powder) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 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. April 2019 PP-DUA-US-0002 v3.0

Rebecca Novak Tibbitt
Rebecca@RNTCommunications.com
Ph: (704) 341-1544

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