Insulin Inhaler Cleared for Use by Diabetics

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The Food and Drug Administration has approved a new type of insulin for people with diabetes. It's inhalable, and it's the first new way to take insulin since the therapy was developed in the 1920s.

FDA officials announced the approval of the new product called Exubera with some exuberance.

"This is a very highly innovative product that will improve the quality of life for millions of Americans with diabetes," said Steven Galson, director of the Center for Drug Evaluation and Research.

Five million people depend on daily insulin injections. Galson was careful to say Exubera is not for everyone. It won't replace all injectable insulin, and shouldn't be used by smokers, people with asthma or other breathing problems. And because studies have not yet been done in children, the FDA approved Exubera only for people 18 and older.

Exubera is fast acting, and is meant to be used at mealtime, to take care of the sudden sharp spike in blood sugar. Some people — including all those with type 1 diabetes — will still have to take a slow acting injectable insulin that continues to work between meals.

Exubera also has some side effects: occasional low blood sugar, coughing, shortness of breath and dry mouth. But overall it appears to be safe, says the FDA's Robert Myer.

"Some patients were studied out as long as seven years. We have a large amount of data from the clinical trials speaking to the safety of this product overall, and the safety of this product in the lungs as well," Myer said.

The FDA has asked the manufacturer, Pfizer, to study the drug's long term effects in 5,000 patients.

Exubera is a powdered form of insulin that comes with a new type of inhaler the size of an eyeglass case.

"It's sort of a device that opens up to have a clear tube at the top," the FDA's Myer explains. "And the bottom, you put in an insulin packet that contains the powder, you cock the device almost the way you would a BB rifle, that forced air forces the insulin into an aerosol in this chamber that the patient then inhales from."

Nathanial Clark, a physician and an official with the American Diabetes Association, noted advantages and disadvantages.

"The advantage of inhaled insulin is that it's inhaled and not injected," he pointed out. "The disadvantage is that patients may find it more cumbersome in comparison to the currently available devices for injectable insulin, such as insulin pens, which have become essentially painless due to the size of the needles, etc."

In addition, Clark said, it's easier to get exactly the right dose in an injection.

A spokeswoman for Pfizer said the product will be available by mid-year. The company hasn't yet set a price.



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