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.

soundoff (914 Responses)
  1. Pumbaa

    It has been approved in Europe – sold under the name Daxas – since last July.
    will be marketed is the United States as DalirespTM

    Why can't the drug companies use the same trade name all over the world? Coca-Cola is the same all over the world, isn't it?
    Doctors have a hard enough time keeping track of drugs with the brand names changing in different countries.

    March 1, 2011 at 19:13 | Report abuse | Reply
    • Subin

      This may be manufactured by diffrent companies tahts why they cannot use the same name.Coke is manufactured all over the world by the same corporate.Also please note the sweetner we add in all our processed food and beverage " HIGH FRUCTOSE CORN SYRUP" IS BANNED IN EUROPE.

      March 2, 2011 at 09:07 | Report abuse |
  2. Bob

    I hope they don't advertise this on TV.. I am sick of all the drug commercials esp around newstime.. Depressing news= selling anti-depressants.. Oh, I see the connection..

    March 1, 2011 at 20:46 | Report abuse | Reply
  3. lynn

    for use on animals to?or just humans?

    March 1, 2011 at 22:42 | Report abuse | Reply
  4. Kelley HYDE

    I'm betting we all noticed the new drug, like all their other drugs, has side effects that would necessitate the use of at least ten more drugs to calm the "side effects", including psychotropics to control those unseemly "moodswings"....

    March 1, 2011 at 22:58 | Report abuse | Reply
    • Mike

      Hyperbolic much? Every medical treatment is a balance of risks and benefits. If the benefits don't make up for the side effects, stop taking the drug. It's not rocket science, genius.

      March 1, 2011 at 23:51 | Report abuse |
  5. beccaa

    And how much is this going to cost? will insurance companies refuse to cover it since it is so new?

    March 2, 2011 at 00:39 | Report abuse | Reply
    • Havildar

      Single payer would take care of it. Instead of the corrupt greedy Insurance companies coming between the patient and their doctor. All Rx drugs should be paid for as long as a Doctor writes the Rx.

      March 2, 2011 at 08:29 | Report abuse |
  6. unretired05

    I already have all the side effects. So who's been slipping this in my coffee?

    March 2, 2011 at 02:14 | Report abuse | Reply
  7. mmi16

    Welcome to the world of tin foil hats!

    March 2, 2011 at 04:59 | Report abuse | Reply
  8. ed Bailey

    Don't laugh, the tin foil hat stops the government from their mind control gimmicks. Just ask Charley sheen and Timmy the LSD guru!

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    • Havildar

      Or Sarah Palin.

      March 2, 2011 at 08:30 | Report abuse |
  9. beccaa

    You would think the insurance companies would be required to cover it, but they aren't. My husband has COPD with asthma and there are two inhalers our insurance have on a 'list' of unapproved pharma. each costs $250 a month. We can 'appeal' to get them covered, but they can't guarantee the outcome. Talk about a death squad...

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  11. di2011

    After 5 days of no noticable exarbations using deliresp, I am quitting the drug. The side effects are worse then the disease, at least for me. I'm wondering if cutting the dosage in half or quartered would give the easy breathing without the harsh side effects. Anyone know if there are different dosages or quartering the pill would be a problem?

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    • Jean Knight

      This is true..... I went to a pulmonary rehab, when first diagnosed. Breathing techiques are helpful on a daily basis with me. My sister just came off this new drug due to the side afects. I have not yet discussed with my doc the possiblitiy of me taking this drug, for I have this lung disease as well. My shortness of breath is getting worse. I am also on several drugs like Zoloft for depression..will this get worse with this drug?? I take Synthroid for low thyroid and preacid for reflux.. I really would like to stop progression of this illness just dont want to be thrown into another cronic ailment resulting from taking new meds. Seems so hopeless..

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    Emphysema also slowly destroys the elastic fibers that hold open the small airways leading to the air sacs. This allows these airways to collapse when you breathe out, so the air in your lungs can't escape. Treatment may slow the progression of emphysema, but it can't reverse the damage. ';*-

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