WASHINGTON (dpa-AFX) - Forest Laboratories Inc. (FRX) and Almirall, S.A. announced that the U.S. Food and Drug Administration or FDA has approved Tudorza Pressair (aclidinium bromide inhalation powder) for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease or COPD, including chronic bronchitis and emphysema.
COPD is a common, progressive, and debilitating lung disease characterized by persistent airflow limitation that makes it hard to breathe; it is currently the third leading cause of mortality in the US. Characteristic symptoms include breathlessness, excessive production of sputum, and a chronic cough.
Tudorza is a twice-daily inhaled long-acting anticholinergic, also referred to as a long-acting muscarinic antagonist or LAMA. Tudorza produces bronchodilation by inhibiting acetylcholine's effect on muscarinic receptors in the airway smooth muscle. Forest expects Tudorza Pressair to be available to wholesalers in the fourth calendar quarter of 2012.
The company said that Tudorza Pressair is not indicated for the initial treatment of acute episodes of bronchospasm i.e., rescue therapy.
In 2005, Forest Laboratories, Inc. licensed U.S. rights for aclidinium from Almirall, while Kyorin Pharmaceutical Co., Ltd holds marketing rights in Japan and Daewoong Pharmaceutical Co., Ltd is licensed to market aclidinium in Korea. Almirall has recently given rights of joint commercialization in the majority of European member states and a number of non-EU countries to Menarini. Almirall maintains rights for the rest of the world.
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© 2012 AFX News
