FDA Approves New Inhaler for COPD
Tudorza Pressair Approved for Long-term Management of COPD
July 24, 2012 -- The FDA has approved a new inhaled drug for the treatment of the lung disease COPD (chronic obstructive pulmonary disease).
The drug, called Tudorza Pressair (aclidinium bromide), is a dry powder inhaler. It improves airflow by relaxing the muscles around the large airways of the lungs. Patients use it twice a day.
Tudorza Pressair is approved for the long-term maintenance of COPD only. It is not a "rescue medication" -- a drug used for sudden breathing problems.
COPD is the umbrella term for chronic lung diseases that include emphysema and chronic bronchitis. The symptoms include:
- chest tightness
- chronic cough
- shortness of breath
- excessive phlegm
Treatment typically involves the use of bronchodilators to open the airways and make breathing easier, and steroids to help reduce airway swelling and mucus production.
Cigarette smoking is the leading cause of COPD.
Tudorza Pressair Approved
The FDA based its approval of Tudorza Pressair on the results of three studies. The studies included more than 1,270 people with COPD.
All the people in the studies had a history of smoking at least one pack of cigarettes a day for 10 years. Those who used Tudorza Pressair showed improvement in lung function measures.
There are some serious side effects associated with Tudorza Pressair. They include:
Common side effects include:
- inflammation of the nasal passage (nasopharyngitis)
Tudorza Pressair is distributed by St. Louis-based Forest Pharmaceuticals.