New COPD drug approved
March 1st, 2011
05:40 PM ET

New COPD drug approved

Some people suffering from chronic obstructive pulmonary disease , or COPD, now have a new weapon in the drug arsenal.  On Tuesday, the U.S. Food and Drug Administration  approved roflumilast, a new class of drug for COPD treatment made by Forest Pharmaceuticals.  The new drug suppresses an enzyme that can cause inflammation in the airways and will be marketed is the United States as DalirespTM.

Last April, the FDA's Pulmonary-Allergy Drugs Advisory Committee voted 10-5 against approving roflumilast, over concerns that the benefits did not outweigh the drugs' risks.

Everyday tips for living with COPD

There are two main forms of COPD: chronic bronchitis and emphysema. Roflumilast is a pill that's taken once a day by patients with severe COPD to alleviate cough and excess mucus linked to bronchitis. It's not to be used to treat COPD involving emphysema.

"COPD is a serious disease that gets worse overtime," said Curtis Rosebraugh, director the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research. "New treatment options that reduce frequency of flare-ups or exacerbations are important in helping patients with COPD associated with chronic bronchitis and a history of exacerbations in managing this debilitating disease."

The leading cause of COPD is cigarette smoking.  According to the American Lung Association, COPD is the fourth-leading cause of death in the United States and can cause serious long-term disability. The ALA says more than 12 million Americans  have COPD but that number could actually be as high as 24 million because many people don't realize they have the disease until it's in the advanced stages.  Symptoms included shortness of breath, a cough with mucus, wheezing, frequent respiratory infections and fatigue.

Dr. Norman Edelman, chief medical officer, American Lung Association said that even with treatment the disease kills about 150,000 people each year. "We have some medications. We are able to treat COPD but they are not dramatic, they afford some relief. This new medication reduced exacerbation by about 15% so it's not a miraculous new cure, but it's certainly a welcome addition in the armamentarium of medications we use to treat this disease."

Roflumilast is not for use in treating sudden breathing difficulties. It comes with a medication guide alerting patients to potential mental health side effects including changes in mood, thinking or behavior. It can also result in unexplained weight loss. Common side effects of the drug include diarrhea, headache, nausea, dizziness, insomnia, back pain and a diminished appetite. It is not recommended for adolescents under 18 years of age.

It has been approved in Europe – sold under the name Daxas – since last July.

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