Controversial COPD Mist Drug Likely to Be Approved by FDA

  • The FDA announced recently that a new mist version of Spiriva is due to be approved for use in the United States, despite some experts' concerns about cardiac risks.


    What It Is


    The new COPD mist drug is an alternate version of the dry powder inhaler known as Spiriva HandiHaler. The active ingredient in this inhaler is tiotropium bromide, which has a well-documented history of reducing COPD exacerbations, also known as flare-ups. The new medicine is called Spiriva Respimat, and is administered in mist form, using a spring-loaded actuator. This version of the medication has been shown to not only reduce COPD flare-ups, but also to reduce bronchospasm, specifically.

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    Why a New Form of an Existing Drug?


    Spiriva HandiHaler is already in use and is effective and relatively safe, so you might be wondering why the drug company is even producing a new version of this medication. Cynics might suggest that it's just another way for the company to make more money from a new product, but there are actually a couple of compelling reasons for this development.


    1. Spiriva HandiHaler has some well-known, though relatively mild, side effects. This form of the drug is an anticholinergic medication, which means it acts by relaxing the large muscles around the airways. Unfortunately, anticholinergics can often cause side effects such as dry mouth, constipation, and urinary retention.


    2. The mist form of Spiriva may be the better choice for certain populations. According to a representative of the drug company that makes Spiriva Respimat who spoke to the FDA, this new form may be the best choice for newly diagnosed COPD patients, those with impaired manual dexterity, and those whose inhalations are weak.


    Spiriva in mist form is already approved in 85 other countries, but the United States tends to be much more cautious than the rest of the world in approving drug therapies.


    The Approval Process


    Spiriva Respimat is not brand new. The drug manufacturer (Boehringer Ingelheim) sought approval for it back in 2007, but the FDA was not convinced of its safety or its effectiveness versus Spiriva HandiHaler at that point in time.


    Since then, Boehringer Ingelheim commissioned an extensive study to look at both of those issues in more detail. Here are the essential facts about the study:

    • Looked at more than 17,000 patients
    • 48-week randomized trial
    • Compared effectiveness against placebo
    • Compared safety against the dry-powder version

    Researchers reported that there were significant findings proving effectiveness. In fact, they found that the medication reduced risk of COPD exacerbation by 31 percent, as compared to placebo.


    Researchers also reported that the drug was proved to be safe, although, like most medications, there were some reported side effects. This is where the controversy came in among FDA panelists (see below).


    These findings were presented to a panel of 13 experts for the FDA's Pulmonary-Allergy Drugs Advisory Committee. 10 out of the 13 members voted that the data supported approval of the drug. The three abstaining members agreed that effectiveness had been proven, but raised ongoing concerns about safety. Generally, the FDA will greenlight drugs based on the expert panel's recommendations, although it is not required to do so.


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    The Controversy


    So, what were the concerns of the three experts who did not vote for approval of Spiriva Respimat? Their concerns centered around a slight increase in risk for cardiac disorders and events, such as heart attack. 


    On the other hand, other experts argued that safety was well-established despite some "niggling concerns."


    Where This Leaves You


    It seems likely that this new medication will be approved for distribution in the U.S. in the near future. If you and your physician are satisfied with your current treatment plan, then you probably do not need to take any action towards changing your medication.


    If, however, you are looking for a change, then this new drug might be worth considering. However, a thorough discussion of risk vs. benefit with your doctor should help you both decide in which direction to move. It's important to note, though, that ALL medication comes with some risk. There are no guarantees that a medication will work exactly the same in every human's body. And treatment is sometimes a matter of trial and error.

Published On: September 03, 2014