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Sunday, 29 January 2006

Inhalable Insulin - Exubera


Dear Reader,

Today we learn about inhalable insulin, which the US Food and Drug Administration has approved of. Pfizer, the pharmaceutical company that created a storm with Viagra, has created an inhalable application of insulin, which does away with the traditional method of using needle injections.

Insulin has been applied by injection since its discovery in 1920. Insulin is not a cure but can save lives of diabetics, whose bodies cannot break down the calories consumed and have, as a result, high sugar in their blood.

Medscape.com has published an article about the development of inhaled insulin by Lutz Heinemann and Tim Heise. The authors noted:

Dermal insulin application does not result in a reproducible and sufficient transfer of insulin across the highly efficient skin barrier. The dream of an 'insulin tablet' has also not become reality, the main problem being digestion and a lack of a specific peptide carrier system in the gut. Nasal insulin application led to a rapid absorption of insulin across the nasal mucosa; however, the relative bioavailability was low and required the use of absorption enhancers. To date, it appears that the pulmonary application of insulin is likely to be the first alternative route of insulin administration to become available within the next few years.


It's not easy being diabetic. However, the new drug, called "Exubera", looks set to change all that. Unfortunately, diabetics are still required to be constantly aware of their blood levels.

Use of rapid-acting inhaled insulin will not replace the need to inject the hormone occasionally, the Food and Drug Administration said. It approved Exubera on Friday, a day after the multinational European Commission did so.

Diabetics also will have to continue pricking their fingers to test blood sugar levels.

Exubera will provide an option for adults with Type 1 or 2 diabetes who are reluctant to use the syringes, pens and pumps currently needed to inject insulin, Pfizer said. In clinical trials, Exubera managed blood sugar levels just as well as injected insulin.

Source: Washington Post


On the other hand, it is possible that inhaled insulin may not meet the requirements of the diabetic. It is possible that the dosage taken is too much or too little.

Inhalable insulin is a welcome advance, said Dr. Nathaniel Clark, the national vice president for clinical affairs for the American Diabetes Association. But he added that needles still allow better dosage control.

.... [skip a few paragraphs...]

"My reaction was, I have excellent control of my blood sugars right now and I just don't have any interest in messing with a good thing," said Rayner, 33, who's used both insulin injections and the pump for her Type 1 diabetes.

Source: Washington Post


Is this worry legitimate? Pfizer, on its website, states otherwise.

Exubera is a fast-acting, dry powder formulation of human insulin that is inhaled into the lungs via the mouth before meals using a simple-to-use, hand-held device that does not require batteries or electricity. The device, which weighs four ounces and is about the size of a carrying case for a pair of eye glasses, is designed to deliver an accurate and precise dose of insulin each time it is used.

Source: Pfizer


The way it seems, one of them must be wrong. But the appliance has been approved both by the US FDA and the European Commission. Does this necessarily mean that the drug is safe for use by the public?

Pfizer itself acknowledges that there are certain caveats to the use of Exubera. First, since the drug is applied nasally, patients who have lung problems will naturally be affected, more so if they are smokers.

Patients should not take Exubera if they have poorly controlled or unstable lung disease, or if they smoke or have stopped smoking less than six months prior to starting Exubera treatment. If a patient starts smoking or resumes smoking, he or she must stop using Exubera and see a health care provider about a different treatment.


The second is that certain patients may experience low blood sugar levels.
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