NDA Submitted for Aclidinium Bromide for COPD
Forest Laboratories and Almirall S.A. announced their submission of a New Drug Application (NDA) to the FDA for aclidinium bromide for the treatment of chronic obstructive pulmonary disease (COPD). The submission includes efficacy data from a large Phase 3 double-blind, placebo-controlled program in which patients received aclidinium bromide 400mcg or 200mcg twice daily or placebo. In the pivotal studies, aclidinium 400mcg twice daily, the proposed dose to be marketed, produced significant improvement in morning trough FEV1 vs. placebo at Week 12 (P<0.0001), the primary endpoint assessed as support for the U.S. NDA.
Aclidinium bromide is a novel, long-acting inhaled anitmuscarinic agent, which is often referred to as an anticholinergic that has a long residence time at M3 receptors and a shorter residence time at M2 receptors. When given by inhalation, aclidinium leads to bronchodilation by inhibiting airway smooth muscle contraction.
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