Almirall, Forest Labs Announce Positive Topline Phase III Study Results for Aclidinium, Formoterol Combination in COPD

Almirall and Forest Laboratories

today announced positive topline results from a six month pivotal phase III clinical trial evaluating the efficacy and safety of fixed dose combinations of aclidinium bromide, (LAMA) and formoterol fumarate (LABA) delivered by Almirall's inhaler Genuair® (Pressair™ in the USA). Both combinations of aclidinium/formoterol (400/6mcg and 400/12mcg given twice a day) demonstrated statistically significant improvements in the co-primary endpoints of change from baseline in morning predose trough FEV1 versus formoterol 12mcg and in FEV1 at 1 hour post-dose versus aclidinium 400mcg at week 24 (p<0.01 and p≤0.0001, respectively). In addition, both combinations of aclidinium/formoterol (400/6mcg and 400/12mcg) provided