Forest Laboratories, Inc. (NYSE:FRX) and Almirall, S.A. (ALM:MC) announced today that Tudorza™ Pressair™ (aclidinium bromide inhalation powder) 400mcg is now available in pharmacies throughout the United States. Tudorza is a long-acting anticholinergic recently approved by the U.S. Food and Drug Administration (FDA) for the long-term, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
Tudorza is the first long-acting inhaled anticholinergic approved by the FDA in over 8 years for COPD and is administered twice daily through the preloaded, multidose Pressair inhaler.
Almirall granted commercialization rights in the U.S. for aclidinium to Forest Laboratories, Inc., Forest and Almirall will co-promote aclidinium in Canada. Almirall maintains rights for the rest of the world.
for more information about Tudorza Pressair.
About Tudorza Pressair
Tudorza Pressair (aclidinium bromide inhalation powder) 400mcg is an anticholinergic for the long-term, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. When given by inhalation, Tudorza produces bronchodilation by inhibiting the muscarinic M3 receptor in the airway smooth muscle.
Tudorza provides statistically significant improvements in bronchodilation, as measured by change from baseline in morning pre-dose trough FEV
at 12 weeks (the primary endpoint) and 24 weeks compared to placebo. Mean peak improvements in lung function (FEV
) assessed after the first dose of Tudorza were similar to those observed at week 12. Tudorza is not indicated for the initial treatment of acute episodes of bronchospasm (ie, rescue therapy).
Tudorza is administered using a multiple-dose dry powder inhaler, Pressair, which delivers 60 doses of aclidinium bromide powder for inhalation. The Pressair inhaler has a colored control window which confirms successful inhalation of the full dose and a dose indicator to let patients know how many doses remain in the inhaler. For a complete description of how to use the Tudorza Pressair inhaler and when to get a new inhaler, see the step-by-step Instructions for Use within the Prescribing Information.