Clinical Geriatrics

FDA Approves New Drug for Treatment of COPD

On July 23, 2012, the FDA approved Tudorza Pressair (aclidinium bromide) for the long-term treatment of bronchospasm, a narrowing of the airways in the lungs that is associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. The new medication, a dry powder inhaler taken twice daily, is a long-acting antimuscarinic agent that improves airflow by relaxing the muscles around the large airways of the lungs. The safety and efficacy of Tudorza Pressair were demonstrated in three randomized, placebo-controlled, confirmatory clinical trials that included 1276 patients over the age of 40 years with a clinical diagnosis of COPD and a history of smoking at least one pack of cigarettes per day for 10 years. The trials demonstrated that, compared with placebo, taking Tudorza Pressair significantly improved airflow; however, rare but serious side effects were observed, including paradoxical bronchospasm, new or worsened acute narrow-angle glaucoma, and new or worsened urinary retention. The most commonly reported side effects were headache, nasopharyngitis, and cough. The drug will be manufactured by Forest Laboratories, Inc.