Forest Labs And Almirall Receive Feedback From FDA On Aclidinium And Formoterol

(RTTNews) - Forest Laboratories Inc. (FRX) and Almirall S.A. announced that they have recently received feedback from the U.S. Food and Drug Administration or FDA regarding the fixed dose combination of aclidinium and formoterol.

Forest Labs stated that 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 of this year.

Forest Labs and Almirall believe that the fixed dose combination of aclidinium and formoterol can be an important therapy for U.S. COPD or Chronic Obstructive Pulmonary Disease patients.

Forest Labs and Almirall completed two pivotal phase III clinical trials for aclidinium/formoterol in the spring of 2013. The combination was administered twice a day and primary end points were met, which demonstrated statically significant improvements versus placebo. In addition, aclidinium/formoterol was well tolerated in both studies.

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 or LAMA that produces bronchodilation by inhibiting the muscarinic M3 receptor in the airway smooth muscle. Formoterol fumarate is a long-acting beta-agonist or LABA that stimulates the B2-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.