Almirall and Forest Laboratories Announce Positive Phase III Study Results for Aclidinium and Formoterol Combination in COPD
April 16 2013 - 2:30AM
Business Wire
Almirall, S.A. (ALM:MC) and Forest Laboratories, Inc. (NYSE:FRX)
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
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