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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