DOCTOR'S VIEW ARCHIVE

Medical Author: Melissa Conrad Stoppler, MD
Medical Editor: Jay W. Marks, MD

The U.S. Food and Drug Administration (FDA) has approved the use of an inhaled insulin preparation for the treatment of adults with both Type 1 and Type 2 diabetes. The first new insulin formulation since its discovery in the 1920s, the drug is marketed under the name Exubera and was approved for adult use on January 27, 2006. Exubera is a powdered, recombinant (genetically engineered), human insulin that has been in development for many years by a team of pharmaceutical companies - Pfizer, Sanofi-Aventis, and Nektar Therapeutics.

The Exubera inhaler is larger than the familiar inhalers used to treat asthma and other breathing conditions. In its most compact form, it is about the size of a flashlight. A retractable tube must be pulled out and a blister package of insulin inserted before the device is used.

To date, the safety and effectiveness of Exubera have been studied in about 2,500 adults with both Type 1 and Type 2 diabetes. However, the FDA notes that some groups of people should not use the new inhaled insulin until further studies of its effectiveness and safety are completed. Specifically, those interested in Exubera should note the following:

A study of people with Type 1 diabetes showed that fewer than 30% of participants were able to maintain recommended blood glucose levels after six months of using inhaled insulin. Therefore, among people with Type 1 diabetes, inhaled insulin may have to be combined with longer-acting traditional injectable insulin preparations for optimal control of blood glucose levels.

Inhaled insulin has not been approved for use in children and teens. Early trials of the drug were stopped due to concerns about potential effects on children's breathing. The manufacturers plan to conduct further studies of the suitability of inhaled insulin in pediatric patients.

Exubera should not be used by smokers, people who have quit smoking within the previous six months, or people suffering from asthma, bronchitis, or emphysema since the long-term effects of the drug on lung tissues have not yet been proven. The FDA has recommended that further studies be carried out to evaluate the safety and effectiveness of inhaled insulin in persons with chronic lung diseases.

Because the long-term effects of Exubera on the lungs are still under investigation, the FDA recommends that lung function be tested after the first 6 months of treatment and every year thereafter, even if there are no pulmonary symptoms.

Other companies also are working on new insulin formulations, including patches, mouth sprays, and oral tablets. Still others are developing their own versions of insulin inhalers.

The FDA requires that detailed medication guides be distributed to all patients taking Exubera. If you are diabetic and taking insulin, your doctor can give you more information and help you decide if you could benefit from trying inhaled insulin.

Reference: FDA News Release P06-13 January 27, 2006

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