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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

lf of this year.

"There are still significant unmet needs in the treatment of COPD. These efficacy and safety data from the Phase II trials are very encouraging," said Lawrence S. Olanoff, M.D., Ph.D., President and Chief Operating Officer of Forest Laboratories. "We look forward to the completion of ACCLAIM I & II trials and continuing the clinical development of aclidinium for the treatment of COPD."

Additional Clinical Data

Three additional clinical trials assessing the safety and pharmacokinetics of aclidinium were also presented at this meeting.

A randomized, double-blind, placebo- and active-controlled clinical trial evaluating the cardiovascular safety and pharmacokinetics of aclidinium (200 or 800 mcg) in 272 healthy subjects, showed no effect on QT interval at doses up to 800 mcg. Furthermore, aclidinium was well-tolerated, with most adverse events being of mild intensity, related to electrode attachment, and of similar incidence across treatment groups. Maximum concentration of aclidinium was reached 5 to 30 minutes post-dose and aclidinium was not detectable in the plasma after one hour.

Results of two other randomized, placebo-controlled studies, each in 16 healthy subjects, were presented. In the first, subjects were exposed to single doses of aclidinium (600 -- 6000 mcg) and placebo to determine pharmacokinetics, safety and tolerability, and maximum tolerated dose. For all doses, aclidinium was undetectable in plasma beyond 3 hours post-dose. Aclidinium was well tolerated across this dosage range, with headache (n=10) and fatigue (n=5) being the most frequently reported adverse events. No serious adverse events were reported. The second study assessed the safety, tolerability, and pharmacokinetics of aclidinium after multiple doses. Subjects received 5 days of treatment with aclidinium 200, 400, 800 mcg or placebo. Aclidinium was undetectable in plasma after all studied doses beyond 1 hour post-dose. Aclidinium was we
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SOURCE Forest Laboratories, Inc.
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