As of January 2006, diabetics can effectively avoid shots when taking insulin. Early this year, the FDA approved Exubera®, an inhaled insulin powder, for treatment of type 1 and type 2 diabetes. This approval came on the coattails of European regulators approval early this year.

 

Approval of Exubera, the brand name of inhaled insulin developed by collaborators Pfizer, Sanofi-Aventis and Nektar Therapeutics, has been right around the corner for more than four years.

 

After years of delays, during which additional clinical evaluations of Exubera were performed, the product received a boost. On September 8, 2005 the Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 7 to 2 in favor of approval.

 

Because Exubera is a first-of-its-kind product and designed for long-term use, on October 28, 2005 the FDA announced that it would need an additional three months to study Pfizer's application.

 

Now, with the recent approval in place, Exubera will be a viable option for diabetics before the end of the year.

The inhaler delivers a cloud of powdered insulin to the lungs where it is absorbed into the bloodstream. Unfortunately, only about ten percent of the drug is actually absorbed and the amount delivered and available for absorption would vary depending on the technique used and the health of the patient. In addition, the current data from Pfizer indicate that the product is only as effective at controlling blood sugar levels as injected insulin, not more so.

 

Pfizer has recommended against approving the drug for use by smokers. During clinical trials Pfizer discovered that participants who smoked absorbed significantly more of the drug that those who did not smoke.

 

The results of early testing of Exubera indicated a drop in lung function for some participants. Pfizer continued to study this result and reported that the drop was not significant. The EMDAC agreed that the product is safe for use by people without lung disease. However, they voted 5 to 4 that the drug's safety for those with lung diseases such as asthma, chronic bronchitis and emphysema, had not been verified.

 

So far, Exubera is approved for management of type 1 and type 2 diabetes in adults only. Pfizer has not sought approval for use in children.

Exubera and other inhaled insulin products are designed to replace the short-acting insulin injections used following meals. Some diabetics will still require long-acting insulin injections at night or in the morning.

 

Most diabetics would likely cut down their insulin injections to once daily if they had an option. A number of pharmaceutical companies are banking on this response.

 

While Exubera is the first inhaled insulin product to be submitted to the FDA for approval, other manufacturers have an inhaled insulin product in the works. Eli Lilly & Co./Alkermes Inc., Novo Nordisk and MannKind Corp. are each working on inhaled insulin, but are still several years behind Pfizer.

 

AIR®Insulin, the inhaled insulin product produced by collaborators Eli Lily & Company and Alkermes Inc. is currently in Phase 3 long-term safety trials.

 

MannKind, a biopharmaceutical company, is also currently in Phase 3 clinical trials in both the US and Europe for its inhaled insulin product (Technosphere® Insulin System) and proprietary delivery device (MedTone® inhaler).

 

Unlike the other powdered inhaled insulin products, Novo Nordisk has partnered with Aradigm to create a liquid inhaled insulin. The AERx® Insulin Diabetes Management system is also in Phase 3 clinical trials.

 

FDA approval of Exubera will pave the way for these and other novel insulin products and will have a profound effect on the future of diabetes management.