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Injection-Free Insulin Inhaler Awaiting FDA Approval

January 24th, 2011 by

A new injection-free insulin inhaler is awaiting FDA approval for the treatment of both type 1 and type 2 diabetes. Insulin can't be taken orally, as digestive juices break it down before it can be used by the body. Currently, the only means of delivering insulin are subcutaneous insulin injections or intravenously.

AFREZZA is an ultra-rapid acting inhaled insulin developed by MannKind Corporation. It uses patented Technospere technology to deliver powdered insulin from a thumb-sized device into the lungs. The lungs are an effective option for delivering diabetes medication, largely because of their huge surface area (about the size of a single tennis court).

AFREEZA is a short-acting mealtime insulin, meaning type 1 diabetics will need to combine it with long-acting insulin for complete diabetes control. Clinical trial participants using the new insulin inhaler experienced less hypoglycemia and weight gain than did controls using a standard combination of long-acting glargine insulin and twice a day 70 30 insulin injections.

Generex Biotechnology Corporation also has a rapid-acting insulin spray in clinical trials. Oral-lyn is a buccal spray insulin which is absorbed through the buccal mucosa (mucous membranes on the inside of the cheeks), bypassing the lungs and quickly entering the blood stream. The inhaled insulin is sprayed in the mouth just before meals, delivering about one unit of human insulin per spray. If approved, it may be the only medication needed by many type 2 diabetics.

Oral-lyn's patented inhalation device resembles an asthma inhaler. Steven Elkman was an Oral-Lyn study participant who successfully managed his type 2 diabetes with the experimental spray insulin. Elkman loved how discreet the inhaler is. "Nobody really notices because so many people use inhalators for asthmatic medication," he says, "It doesn't really attract any attention."

The FDA actually approved the first inhaled insulin, called Exubera, to treat type 1 and type 2 diabetes in 2006. It was a short-acting powdered form of recombinant human insulin, delivered into the lungs through an insulin inhaler. But the new system of insulin delivery never really caught on, and Pfizer dropped the novel diabetes medication from the market a year later. AFREZZA is easier to use, faster acting and boasts better bioavailability than Exubera, enabling diabetics to achieve better insulin levels using smaller amounts.

Patients in clinical trials of the new inhaled insulins have reported enhanced quality of life, overall satisfaction, and greater acceptance of being insulin dependent. Dr. Larry Deeb, a pediatric endrocrinologist from the University of Florida College of Medicine, says that finding an alternative to insulin injections is crucial, especially for children and the needle-phobic. "Insulin administration is a huge issue for people with diabetes," he stresses, "You have to appreciate the fear [of injections]. Insulin omission is one of the major issues in diabetes."


annie yoon says at 2013-10-21 16:38:03:

I love it

keep me posted please

hope FDA O.K.it

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