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.
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 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.
COPD, or chronic obstructive pulmonary disease, is a common, progressive, and debilitating lung disease characterized by persistent airflow limitation that makes it hard to breathe. The World Health Organization (WHO) has described COPD as a global epidemic; an estimated 64 million people have COPD worldwide. More than 3 million people died of the condition in 2005, which is equal to 5% of all deaths globally that year. Total deaths from COPD are projected to increase by more than 30% in the next 10 years without interventions to cut risks, particularly exposure to tobacco smoke. WHO predicts that COPD will become the third leading cause of death worldwide by 2030. COPD is already the third leading cause of death in the U.S.
In patients with COPD the airways in the lungs typically lose their elasticity, produce excess mucus and become thick and inflamed, limiting the passage of air. The most common symptoms of COPD are breathlessness (or a “need for air”), abnormal sputum (a mix of saliva and mucus in the airway), and chronic cough. As the condition worsens and breathlessness increases, daily activities, such as walking up a short flight of stairs or carrying a suitcase, can become very difficult. New therapies to treat this debilitating disease may be of value.
Almirall is a pharmaceutical company committed to innovate through valuable medicines. Headquartered in Barcelona, Spain, it researches, develops, manufactures and commercialises its own R&D and licensed drugs with the aim of improving people’s health and wellbeing now and to future generations. Almirall medicines, focused on respiratory, dermatology, gastrointestinal and pain, are currently in over 70 countries while the company has direct presence in Europe, Mexico and Canada through 13 affiliates.
Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories’ Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings. Forest assumes no obligation to update forward-looking statements contained in this release to reflect new information or future events or developments.