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New Long-Term Treatment for COPD Approved by FDA

One of nation’s biggest killers is most often found in senior citizens, current or former smokers, women

July 31, 2014 - A new long-term treatment for the third largest killer of U.S. citizens - chronic obstructive pulmonary disease (COPD) – was approved today by the U.S. Food and Drug Administration. Striverdi Respimat (olodaterol), an inhalation spray, is for the treatment of patients with COPD, including chronic bronchitis and emphysema that are experiencing airflow obstruction. Striverdi Respimat can be used once daily over a long period of time.

COPD, which is most prevalent among senior citizens, especially those age 65 to 74, is a serious lung disease that makes breathing difficult and worsens over time. Symptoms include wheezing, cough, chest tightness, and shortness of breath. Cigarette smoking is the leading cause of COPD.

According to the National Heart, Lung, and Blood Institute, COPD is the third leading cause of death in the United States.

“The availability of this new long-term maintenance medication provides an additional treatment options for the millions of Americans who suffer with COPD,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.

 

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Striverdi Respimat is a long-acting beta-adrenergic agonist (LABA) that helps the muscles around the airways in the lungs stay relaxed to prevent symptoms.

The safety and effectiveness of Striverdi Respimat was evaluated in 3,104 people diagnosed with COPD. People who received Striverdi Respimat showed improved lung function compared to placebo.

Warnings

The drug carries a boxed warning that LABAs increase the risk of asthma-related death. The safety and effectiveness of Striverdi Respimat in people with asthma has not been established and it is not approved to treat asthma.

Striverdi Respimat should not be used as a rescue therapy to treat sudden breathing problems (acute bronchospasm).

Striverdi Respimat should not be used in patients with acutely deteriorating COPD and may cause serious side effects, including narrowing and obstruction of the respiratory airway (paradoxical bronchospasm) and cardiovascular effects.

The FDA approved Striverdi Respimat with a patient medication guide that includes instructions for use and information about the potential risks of taking the drug.

Side Effects

The most common side effects reported by people using Striverdi Respimat in the clinical study were nasopharyngitis (runny nose), upper respiratory tract infection, bronchitis, cough, urinary tract infection, dizziness, rash, diarrhea, back pain and arthralgia (joint pain).

Striverdi Respimat is distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

About COPD from Centers for Disease Control and Prevention (CDC)

Chronic Obstructive Pulmonary Disease, or COPD, refers to a group of diseases that cause airflow blockage and breathing-related problems. It includes emphysema, chronic bronchitis, and in some cases asthma.

What causes COPD?

In the United States, tobacco smoke is a key factor in the development and progression of COPD1, although exposure to air pollutants in the home and workplace, genetic factors, and respiratory infections also play a role. In the developing world, indoor air quality is thought to play a larger role in the development and progression of COPD than it does in the United States.

Who has COPD?

Chronic lower respiratory disease, primarily COPD, was the third leading cause of death in the United States in 2011.

Fifteen million Americans report that they have been diagnosed with COPD.

More than 50% of adults with low pulmonary function were not aware that they had COPD; therefore the actual number may be higher.

The following groups were more likely to report COPD:

    • People aged 65–74 years.

    • Non-Hispanic whites.

    • Women.

    • Individuals who were unemployed, retired, or unable to work.

    • Individuals with less than a high school education.

    • People with lower incomes.

    • Individuals who were divorced, widowed, or separated.

    • Current or former smokers.

    • Those with a history of asthma.

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