New Diabetes Treatment to Hit the Market This Summer
Many diabetics will now want to take a deep breathe—literally. In January, the US Food and Drug Administration (FDA) approved the first inhaled insulin to treat ]]>type 1]]> and ]]>type 2]]> diabetes. The approval may mean relief for the five million Americans who control their diabetes by needle injection, currently the only available way to administer insulin.
The inhaled form of insulin will be sold by Pfizer Inc. under the brand name Exubera. Although the product will not be available until June or July, many are already seeing promise in the way Exubera will revolutionize diabetes treatment.
“It is our hope that the availability of inhaled insulin will offer patients more options to control their blood sugars.” said Steven Galson, MD, Director, FDA Center for Drug Evaluation and Research in an FDA press release.
The product consists of an inhaler and dry powder form of human insulin. The rapid-acting insulin is inhaled through the mouth where it enters the lungs and then the bloodstream. The portable inhaler is compact, weighing four ounces and about the size of an eyeglass case when closed.
Assessing Exubera’s Effectiveness
Clinical studies of Exubera have involved around 2,500 adults with type 1 or type 2 diabetes observed over an average of 20 months. Researchers say that Exubera appears to be safe with short-term use. The product seems to be as effective as short-acting insulin injections, and significantly improves blood sugar levels when taken with diabetes pills.
In the studies, peak insulin concentration was reached faster using Exubera versus regular insulin by injection. Moreover, many who took the inhaled form of insulin preferred it over injection or diabetes pills.
Exubera is meant to be taken before meals and is approved for adults 18 years and older. People with type 2 diabetes will be able to use it alone or in combination with diabetes pills or longer-acting insulin injections, while those with type 1 diabetes will use Exubera only in combination with longer-acting insulin injections.
However, Exubera is not recommended for all diabetics. The FDA states that smokers, and those who stop smoking less than six months prior to treatment, should not use Exubera. Diabetics with lung disease, including ]]>asthma,]]>]]>bronchitis]]> , ]]>chronic obstructive pulmonary disease (COPD)]]> , and ]]>emphysema]]> , also are advised not to use the product.
Those who take Exubera will need to monitor their blood sugar levels because, as with any insulin product, Exubera can cause low blood sugar. Other side effects include shortness of breath, cough, sore throat, and dry mouth.
Researchers still have more to learn about Exubera, including potential risks and long-term effects. They plan to continue studies after it is marketed. Also, the price for this new treatment is yet to be determined, but will likely be expensive.
Doctors are hopeful, however, that the inhaled form of insulin will not only provide a convenient way for people to control their diabetes, but also attract those diabetics who have been delaying aggressive treatment because of the inconvenience or fear associated with needles. Diabetics who maintain tighter control over their blood sugars over the long-term have been shown to lower their risk of serious complications, such as blindness, ]]>kidney failure]]> , and limb amputation.
American Diabetes Association
U.S. Food and Drug Administration
Facts about Exubera. Pfizer Inc. website. Available at: http://www.pfizer.com/pfizer/download/exubera_release_faq.pdf . Accessed February 2, 2006.
FDA approves first ever inhaled insulin combination product for treatment of diabetes [press release]. Rockville, MD: US Food and Drug Administration; January 27, 2006.
FDA approves inhalable insulin. American Diabetes Association website. Available at: http://www.diabetes.org/diabetesnewsarticle.jsp?storyId=11344793&filename= 20060128/washingtonpost20060128engwashingtonpostwpniengwashingtonpostwpni 1040407591212392510637864EDIT.xml. Accessed February 2, 2006.
Pfizer receives FDA approval for Exubera, the first inhalable form of insulin for controlling type 1 and type 2 diabetes in adults [press release]. New York, NY: Pfizer Inc.; January 27, 2006.
Image credit: Pfizer Inc.
Last reviewed February 2006 by ]]>Richard Glickman-Simon, MD]]>
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