Almirall and Forest Laboratories have announced that a 6-month Phase 3 study of their aclidinium bromide/formoterol fumarate dry powder fixed dose combination delivered by the Genuair (Pressair) inhaler for the treatment of COPD demonstrated statistically significant improvements with both doses tested.
The study of more than 1,700 patients found that both the 400/6mcg and 400/12mcg doses of aclidinium/formoterol given twice daily produced statistically significant increases in FEV1 versus the individual components alone and versus placebo.
Almirall Chief Scientific Officer Bertil Lindmark commented, “We expect this novel combination of aclidinium/formoterol to offer patients a new option in COPD treatment. In addition to the improved efficacy shown in this study, the safety profile was comparable to placebo. Indeed, these positive results confirm Almirall’s potential to build an innovative worldwide respiratory franchise around our Genuair device and aclidinium bromide (Eklira/Bretaris).”
Almirall and Forest launched the Tudorza Pressair aclidinium DPI in the US at the end of 2012. The product was approved as the Eklira/Bretaris Genuair aclidinium DPI in Europe.
The companies say that if a second Phase 3 trial of the combination product produces successful results — expected in a few weeks — the data “will support our intention to file an NDA with the FDA and an MAA to the EMA.”
Read the Almirall/Forest press release.
