Policy & Regulation
US Food and Drug Administration Approves Duaklir Pressair for Patients with Chronic Obstructive Pulmonary Disease
22 April 2019 - - 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, US-based Circassia Pharmaceuticals Inc said.

Duaklir Pressair is a fixed-dose LAMA/LABA combination of the long-acting muscarinic antagonist aclidinium and the long-acting beta agonist formoterol. It is administered twice daily via the pre-loaded, breath-actuated, Pressiar multi-dose inhaler.

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 commercialisation rights to Duaklir Pressair and AstraZeneca is responsible for the product's development and regulatory submission.

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.

According to the American Lung Association, COPD is the third leading cause of death in the United States. More than 11m people have been diagnosed with COPD, but millions more may have the disease without knowing it.

COPD causes serious long-term disability and early death, and the number of people dying from COPD is growing.

The most common symptoms of COPD are breathlessness, chronic cough, and sputum (mucus) production.

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.

These episodes can be seriously disabling and result in the need for urgent medical care (including hospitalisation) and sometimes death.

Please see complete Important Safety Information below and full prescribing information here.

Duaklir is administered via the Pressiar Inhaler. The Pressair inhaler has shown to be preferred by patients when compared to other inhaler devices commonly used for COPD.

Pressiar is a multi-dose dry powder inhaler 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.

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

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.

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.