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Inhaled-Insulin Sales Approved BRs Pennington Center Tested Drug, Alternate to Injections

Posted on: Saturday, 28 January 2006, 18:00 CST

By EMILY KERN

Inhaled-insulin sales approved

BRs Pennington center tested drug, alternate to injections

Diabetics unable to endure daily shots of insulin soon should have an alternative through the help of researchers at Pennington Biomedical Research Center.

The federal government Friday approved the first version of insulin that is inhaled, not injected.

The Pfizer Inc. insulin, called Exubera, was approved by the Food and Drug Administration for adults with either Type 1 or Type 2 diabetes.

The FDA said Exubera is the first new way of delivering insulin since the discovery of the hormone in the 1920s. Pfizer jointly developed the drug and dispenser with Sanofi-Aventis and Nektar Therapeutics.

A team led by Dr. William Cefalu conducted clinical trials of the drug at Pennington Biomedical Research Center.

Cefalu, chief of the division of nutrition and chronic diseases at Pennington, said he presented his results to the FDA.

The inhaled insulin should be available in the very near future, certainly within the year, Cefalu said.

Exubera is insulin in powdered form that is placed into a hand- held device that vaporizes it, Cefalu said.

The dose is taken before meals. The body absorbs the insulin vapors, which simulates the way people without diabetes produce the hormone when they eat, he said.

The American Diabetes Association estimated that nearly 21 million people in the U.S. have diabetes, although about one-third do not know it. The number of people with diabetes is believed to have tripled in the past quarter-century. About 5 million Americans now inject insulin daily.

However, about 15 percent of diagnosed diabetics do not take the insulin or pills they should, according to the American Diabetes Association. Better control of blood sugar levels allows diabetics to ward off other serious complications, including diseases of the eye, kidneys and nerves. The latter can lead to ulcers and infections in the legs and feet and, in some cases, amputations.

Cefalu said he hopes the inhaled insulin will cause patients who might be too squeamish for injections to start diabetes treatment earlier.

I personally think this will be a major change in the sense that a large number of Type 2 diabetics who had put off treatment will now opt for this kind of therapy, Cefalu said.

I think its going to change the diabetes landscape by breaking down current barriers of insulin use, he added.

Use of the rapid-acting insulin will not replace the need to inject the hormone occasionally.

Adults with either Type 1 diabetes (called juvenile diabetes) or Type 2 diabetes (often called adult-onset diabetes) could use the inhaled insulin before and after meals to manage their blood-sugar levels, Cefalu said. However, the drug would not replace the longer- acting insulin injections that some diabetics, particularly those with Type 1, need to take in the morning or before bed.

Inhalable insulin is welcome, said Dr. Nathaniel Clark, but needles are still needed by some patients to control dosage.

Injecting insulin is far more precise in the sense of, what you want to deliver you deliver, said Clark, the national vice president for clinical affairs for the American Diabetes Association.

You dont have to deal with any questions of how much is delivered through the lungs, he added.

The FDA delayed its decision on Exubera by three months so it could review chemistry data on the diabetes treatment. The European Commission approved Exubera on Thursday for use in adults.

Clinical trials found that Exubera managed blood-sugar levels just as well as injected insulin. But an independent FDA panel in September also stressed that use of inhaled insulin will not mean diabetics can toss out the needles, pens or pumps used to inject the hormone. And diabetics will have to continue pricking their fingers to test blood-sugar levels.

The FDA review panel also expressed concern about the bulkiness of the Exubera dispenser and about some patients who experienced coughing or a slight decrease in lung capacity when using the drug.

Pfizer will conduct studies on the long-term effects of Exubera on the lungs, as well as the safety and effectiveness of the drug on patients with lung disease, the FDA said.

Diabetics with asthma, poorly controlled or unstable lung disease, or who smoke or recently quit, shouldnt use Exubera, the FDA said. And patients should have their lungs checked before using the drug, as well as at six- to 12-month intervals after that.

The Associated Press contributed to this report.

Source: Advocate; Baton Rouge, La.

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