Duaklir Genuair ( Aclidinium bromide / Formoterol fumarate 340/12 mcg ) has been granted marketing authorisation by the European Commission ( EC ) to be used as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease ( COPD ).
Duaklir is a fixed-dose combination of already-approved Eklira ( Aclidinium bromide ), a long-acting muscarinic-antagonist ( LAMA ), with the long-acting beta-agonist ( LABA ) Formoterol.
The twice-daily therapy is the only LAMA/LABA combination to show statistically significant improvement in breathlessness compared to individual therapies and is administered by the Genuair dry powder inhaler device.
The European Union approval of Duaklir Genuair was based on efficacy and safety data from more than 2,000 patients in 11 clinical studies, conducted in 29 countries worldwide.
Results showed that Duaklir Genuair demonstrated statistically significant and sustained improvement in the lung function compared to monotherapy, providing a favourable benefit-to-risk profile.
Aclidinium bromide is an anticholinergic or long acting muscarinic antagonist ( LAMA ) that produces bronchodilation by inhibiting the muscarinic M3 receptor in the airway smooth muscle.
Formoterol fumarate is a long-acting beta-agonist ( LABA ) that stimulates the beta2-receptors in the bronchial smooth muscle resulting in bronchodilation.
The phase III clinical development programme included approximately 4,000 patients with a clinical diagnosis of COPD. The programme comprised of two 6-month randomised, control- and active-controlled studies, ACLIFORM-COPD ( LAC 30 ) - ( ACLIdinium/FORMoterol fumarate combination for Investigative use in the treatment of moderate to severe COPD ) and AUGMENT ( LAC 31 ) - ( Aclidinium/formoterol FUmurate Combination for InvestiGative use in the TreatMENT of Moderate to Severe COPD ); a 6-month extension of the AUGMENT study ( LAC 36 ); and a further long-term 12-month randomised controlled study comparing Aclidinium / Formoterol 340/12 to Formoterol ( LAC 32 ). ( Xagena )
Source: AstraZeneca, 2014