Two Phase 3 studies to evaluate the safety of twice daily doses of a fixed dose combination dry powder formulation of aclidinium bromide and formoterol fumarate in 3,500 patients with moderate to severe COPD have been initiated by Almirall and its US partner, Forest Laboratories. The 24-week studies are taking place in Europe and North America, along with a 52-week long-term safety study in North America.
Almirall Chief Scientific Officer Bertil Lindmark commented, “After the filing of aclidinium monotherapy in Europe and the USA, the start of this global Phase 3 program of the fixed dose combination of aclidinium and formoterol, in more than 25 countries, means that Almirall is progressing in expanding the aclidinium franchise. We are aiming to provide innovative treatment options for patients suffering from debilitating respiratory diseases, as is the case of COPD.”
Forest and Almirall submitted an NDA for aclidinium bromide to the FDA in June 2011, and Almirall submitted an MAA to the EMA a month later.
Read the Almirall press release.
