Forest and Almirall Announce Positive Results of Clinical Studies for Aclidinium Bromide, a Novel, Long-Acting Anticholinergic f

Data Presented at the 2008 International Conference of the American Thoracic Society 


TORONTO, May 20  /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. and Laboratorios Almirall, S.A. today presented results from four clinical trials assessing the efficacy and safety of aclidinium bromide, an investigational treatment for chronic obstructive pulmonary disease (COPD). Data from four preclinical studies further describing the properties of aclidinium were also presented at the meeting.

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Presentations included data from a 464-patient randomized, double-blind, four-week, Phase IIb study that evaluated both the efficacy and tolerability of once-daily aclidinium (25 mcg, 50 mcg, 100 mcg, 200 mcg or 400 mcg) or placebo in patients with moderate to severe COPD. An open-label tiotropium (18 mcg) arm was included as an active control. The study demonstrated aclidinium (200 mcg and 400 mcg), administered via a multi-dose dry powder inhaler, significantly increased trough (24-hour) forced expiratory volume in one second (FEV1) -- an important measure of lung function -- on Day 29 compared with placebo (p