Forest & Almirall Announce Submission of New Drug Application for Aclidinium Bromide for the Treatment of Chronic Obstructive...
June 30 2011 - 2:00AM
Business Wire
Forest Laboratories, Inc. (NYSE: FRX) and Almirall, S.A.
(ALM.MC) announced they have recently submitted a New Drug
Application (NDA) to the U.S. Food and Drug Administration (FDA)
for aclidinium bromide, a long-acting inhaled antimuscarinic agent
developed for the treatment of COPD.
The submission includes efficacy data from a large Phase III
double-blind placebo-controlled program in which patients received
aclidinium bromide 400 mcg or 200 mcg twice daily or placebo. In
the pivotal studies, aclidinium 400 mcg twice-a-day, the proposed
to-be-marketed dose, produced significant improvement in morning
trough FEV1 versus placebo at week 12 (p
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