FDA approves Tudorza Pressair for COPD

The Food and Drug Administration recently approved Tudorza Pressair (aclidinium bromide) for the long-term maintenance treatment of bronchospasm (narrowing of the airways in the lung) associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. COPD is a serious lung disease that makes breathing difficult for many nursing home residents. COPD is the fourth leading cause of death in the United States. Symptoms can include chest tightness, chronic cough, and excessive phlegm.

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.

“COPD is a serious disease that gets worse over time,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in FDA’s Center for Drug Evaluation and Research. “The availability of long-term maintenance drugs for COPD provides additional treatment options for the millions of people who suffer with this debilitating disease.”