The drug, Tudorza Pressair (aclidinium bromide), distributed by Forest Pharmaceuticals in St. Louis, is approved to help these patients with a condition in which their airways in the lung become narrower, called "bronchospasm."
"Ask your doctor about treatment options for COPD."
The drug is delivered twice daily in powder form through an inhaler. It works by relaxing the muscles around the lung's airways to improve airflow through the lungs.
COPD is an umbrella term describing damage to the lungs that can restrict how well a person can breathe. It includes both chronic bronchitis and emphysema, two related conditions most commonly caused by cigarette smoking.
In chronic bronchitis, inflammation in the lungs leads to swollen, irritated air passages and increased mucus production.
Emphysema, on the other hand, involves a breaking down of the tiny air sacs in the lungs. As they disintegrate and create larger air spaces in the lungs, there is less surface area for oxygen to be transferred to the lungs, leading to breathlessness.
The symptoms of COPD, the fourth leading cause of death in the US, include chest tightness, chronic coughing and having excessive amounts of phlegm.
“COPD is a serious disease that gets worse over time,” said Curtis Rosebraugh, MD, MPH, 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.”
Three clinical trials involving 1,276 participants were conducted to establish the safety and effectiveness of Tudorza Pressair. All the participants were at least 40 years old, had been diagnosed with COPD and had smoked a pack of cigarettes a day for at least 10 years.
There are a number of serious side effects that can occur with use of this new drug, including a condition called "paradoxical bronchoplasm," in which the medication does the opposite of what it is supposed to do.
Other serious side effects can include increased pressure in the eyes (called "acute narrow-angle glaucoma") or an inability to urinate.
The most common and typical side effects are headache, inflammation of the nasal passages (similar to a cold) and a cough.
The FDA recommends that Tudorza Pressair only be used in patients aged 18 and older and should not be used as an emergency therapy for treatment of sudden breathing problems.
The drug's approval was announced by the FDA on July 23.