Almirall + Forest report feedback from FDA for aclidinium bromide + formoterol fumarate combination for COPD

Forest Laboratories, Inc. and Almirall, S.A. announced that they have recently received feedback from the FDA regarding the fixed dose combination of aclidinium and formoterol. Although no new issues have arisen, further discussion is needed with the Agency in order to address questions related to CMC (Chemistry, Manufacturing and Control) and a Type C meeting with the FDA is going to be requested, likely to be held during third quarter 2014 .

Aclidinium bromide /formoterol fumarate is an investigational fixed dose combination of two approved long-acting bronchodilators with different mechanisms of action and similar pharmocodynamic profiles. Aclidinium bromide is an anticholinergic or long-acting muscarinic antagonist (LAMA) that produces bronchodilation by inhibiting the muscarinic M3 receptor in the airway smooth muscle. Formoterol fumarate is a long-acting beta-agonist (LABA) that stimulates the 2-receptors in the bronchial smooth muscle resulting in bronchodilation. Both aclidinium bromide (Tudorza/ Eklira) and formoterol fumarate are approved for the maintenance treatment of COPD in the United States and Europe.