Duaklir (aclidinium bromide and formoterol fumarate), a long-term maintenance treatment for chronic obstructive pulmonary disease (COPD), is available to patients living in the U.S., Circassia Pharmaceuticals announced.
According to the company, the product became available on Oct. 21. The U.S. Food and Drug Administration (FDA) had approved it in April 2019.
“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,” David Acheson, senior vice president U.S. Commercial of Circassia, said in a press release.
“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 U.S. market,” Acheson said.
Duaklir combines the long-acting muscarinic antagonist (LAMA) aclidinium bromide with the long-acting beta agonist (LABA) formoterol fumarate, which together trigger relaxation of smooth muscles surrounding the airways, making it easier for people with COPD to breathe.
Like Tudorza (aclidinium bromide), another COPD treatment marketed by Circassia, Duaklir should be administered twice-a-day using the Pressair inhaler, a plastic, portable device that should be placed in the patient’s mouth to dispense precise amounts of the medication that are then inhaled.
Duaklir has been approved globally, including in the European Union, under different brand names. Its approval was based on findings from three Phase 3 clinical trials — ACLIFORM (NCT01462942), AUGMENT (NCT01437397), and AMPLIFY (NCT02796677) — and the Phase 4 ASCENT-COPD study (NCT01966107).
These trials showed that Duaklir effectively reduced the number of COPD flare-ups, and improved patients’ lung functions, and that the combination of aclidinium bromide and formoterol fumarate offered more clinical benefits than the individual components.
During the meeting, Circassia hosted a respiratory educational reception to present posters featured in previous meetings in the U.S. and Europe containing the major findings of the AMPLIFY and ASCENT-COPD trials.
In 2017, Circassia signed an agreement with AstraZeneca to develop and commercialize both Tudorza and Duaklir in the U.S. By the end of last year, Circassia had acquired the full commercial rights for both medications in the country.