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FDA Approves New Inhaler for COPD 2012-07-26
By Denise Mann

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.

Slideshow: A Visual Guide to 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:

    high blood pressure in the eyes (acute narrow-angle glaucoma)
    wheezing
    urinary retention

Common side effects include:

    headache
    inflammation of the nasal passage (nasopharyngitis)
    cough

Tudorza Pressair is distributed by St. Louis-based Forest Pharmaceuticals.


 
 
 
Patent Pending:   60/481641
 
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