The FDA today approved Tudorza Pressair (aclidinium bromide) for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
COPD is a serious lung disease encompassing both chronic bronchitis and emphysema. Cigarette smoking is the leading cause of COPD. Chronic bronchitis is an inflammatory response (usually following many years of smoking) leading to proliferation of goblet cells with excess mucus production, leading to airway obstruction. The chronic inflammation, edema, and fibrosis also lead to increases in airway tissue thickness. These changes lead to the symptoms of chest tightness, chronic cough, and excessive phlegm. Emphysema is similarly linked to smoking, though in a very small proportion of patients it is due to genetic deficiency of α1-antitrypsin. Emphysema is accompanied by marked destruction of the alveoli, leading to dilatation, with reduced elastic recoil of the airways, so the airways are held open during expiration.
Tudorza Pressair, a dry powder inhaler used twice daily, is a long-acting antimuscarinic agent that helps muscles around the large airways of the lungs stay relaxed to improve airflow.
The safety and efficacy of Tudorza Pressair were demonstrated in three randomized, placebo-controlled confirmatory clinical trials that included 1,276 patients ages 40 and older with a clinical diagnosis of COPD. Those treated had a smoking history of at least one pack a day for 10 years.
Tudorza Pressair may cause serious side effects, including paradoxical bronchospasm, new or worsened increased pressure in the eyes (acute narrow-angle glaucoma), or new or worsened urinary retention. Tudorza Pressair should not be used as a rescue therapy to treat sudden breathing problems (acute bronchospasm) and is not recommended for people younger than 18 years. The most common side effects reported by patients using Tudorza Pressair include headache, inflammation of the nasal passage (nasopharyngitis), and cough.
Tudorza Pressair is distributed by St. Louis-based Forest Pharmaceuticals, a subsidiary of Forest Laboratories.