The pharmaceutical company- Circassia has announced the approval of the U.S. Food and Drug Administration (FDA) for the company’s medication of Duaklir which is used for maintenance treatment of chronic obstructive pulmonary disease (COPD). As a result, the manufacturing organization has planned to launch the therapy in the United States in the second half of 2019.
The medication- Duaklir is a mixture of two long-acting bronchodilators: aclidinium bromide (400 mcg) and formoterol fumarate (12 mcg). The medicine is applied twice daily, by means of a Pressair inhaler, which is a plastic device, meant to automatically deliver medication upon inhalation.
The caliber of the airways is increased through the medium of the two bronchodilators, while it also helps in relaxing the smooth muscle tone.
Special features of aclidinium bromide is that it is capable of acting like a long muscarinic antagonist (LAMA), while it also blocks muscarinic receptors, and prevents airway construction. On the other hand, formoterol fumarate is a long-acting beta antagonist (LABA), which activates the beta-adrenergic receptors.
According to reports, the FDA approval is dependent on positive results from phase 3 studies and from phase 4 ASCENT study (NCT01966107), which can effectively reduce COPD exacerbations. Phase 3 includes ACLIFORM (NCT01462942), AUGMENT (NCT01437397), and AMPLIFY (NCT02796677).
“Duaklir’s approval is based on a broad clinical database, including data demonstrating a reduction in the risk of COPD exacerbations driven by its aclidinium component, and we look forward to making this new therapeutic option available to patients across the United States,” reports Asmus.