Tudorza™ Pressair™ Approved for COPD Symptoms

Cincinnati—The Institute of Medicine recently deemed chronic obstructive pulmonary disease (COPD) as a priority, identifying its risks and associated costs. The total yearly cost of COPD is $49.9 billion, while direct costs are $29.5 billion, according to Shari Fine, DO, medical director at Humana.

Healthcare costs are 3.5 times higher for COPD patients than for patients who do not have COPD, according to Dr. Fine.

In July, the FDA approved Tudorza^™ Pressair^™ (aclidinium bromide inhalation powder), a dry powder inhaler indicated for the long-term maintenance of bronchospasm associated with COPD. It was the second FDA-approved long-acting anticholinergic for COPD, following the 2004 approval of the Spiriva^® HandiHaler^® (tiotropium bromide inhalation powder). Aclidinium bromide is not indicated as initial treatment for acute episodes of bronchospasm.

Dr. Fine provided an overview of aclidinium bromide at the AMCP meeting in a product theater sponsored by Forest Laboratories, Inc., the manufacturer of the drug.

Dr. Fine mentioned the Global Initiative for Chronic Obstructive Lung Disease (GOLD), which began in 1997 as a collaboration of the National Heart, Lung, and Blood Institute, National Institutes of Health, and the World Health Organization. She said the GOLD guidelines should be used to make treatment recommendations for COPD, a preventable and treatable disease that limits airflow. Risk factors for COPD include tobacco smoking and air pollution.

According to the GOLD guidelines, long-acting inhaled bronchodilators such as aclidinium bromide “are convenient and more effective at producing maintained symptom relief than short-acting bronchodilators” and “reduce exacerbations and related hospitalizations and improve symptoms and health status.”

The effectiveness of aclidinium bromide was based on 3 placebo-controlled trials (2 three-month and 1 six-month) that included 636 patients with COPD who took the recommended dose of 400 mcg of aclidinium bromide twice daily. The mean age was 64 years, while 58% of patients were males, and 94% were Caucasians. Patients were excluded if they had cardiac disease, narrow-angle glaucoma, symptomatic prostatic hypertrophy, or bladder outlet obstruction.

Aclidinium bromide’s safety was based on 3 studies (2 double blind and 1 open label) ranging from 40 to 52 weeks in 891 patients with moderate to severe COPD. In placebo-controlled studies, the most common adverse reactions were headache, nasopharyngitis, cough, diarrhea, sinusitis, rhinitis, toothache, falling, and vomiting.

During the 3 placebo-controlled trials, the researchers examined 197 patients who were <60 years of age, 272 patients who were between 60 and 70 years of age, and 167 patients who were ≥70 years of age. Dr. Fine noted there were no overall differences in the groups with regard to safety or effectiveness.

Dr. Fine warned that aclidinium bromide should be used with caution in patients with narrow-angle glaucoma and urinary retention. Symptoms of acute narrow-angle glaucoma include eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion, and corneal edema. Symptoms of urinary retention include difficulty passing urine and painful urination.

In addition, after administration with aclidinium bromide, patients sometimes have immediate hypersensitivity reactions. If that occurs, patients should stop taking aclidinium bromide.

Aclidinium bromide has not been tested in pregnant women, and its effect on labor and delivery is unknown. Dr. Fine said aclidinium bromide should only be used in pregnant women or during labor or delivery if the potential benefit to the patient justifies the potential risk to the fetus.