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Forest and Almirall Announce Positive Results of Clinical Studies for Aclidinium Bromide, a Novel, Long-Acting Anticholinergic for the Treatment for COPD
Date:5/20/2008

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.

(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )

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<0.05 vs placebo). There was a dose response observed for lung function improvement with once-daily aclidinium. Aclidinium was well tolerated, with no dose-dependent effect on ECG, laboratory parameters, or adverse events. Overall, the most frequently reported adverse events were headache (4.1% of patients), dry mouth (2.8% of patients), exacerbation of chronic obstructive airways disease (1.7% of patients) and cough (1.7% of patients). Based on these results, aclidinium 200 mcg administered once every 24 hours was selected as the dose for investigation in the two ongoing Phase III clinical trials, ACCLAIM COPD I and II, which are expected to report out during the second ha
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SOURCE Forest Laboratories, Inc.
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