Injection-Free Insulin Inhaler Awaiting FDA Approval

January 24th, 2011

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."

Insulin Therapy Changing With New and Improved Insulin Delivery Methods

April 14th, 2011

An old insulin syringe
Not that long ago, being insulin dependent meant you had to carry around a syringe and a vial of insulin to deliver your insulin injections, making sure to keep them refrigerated. There are now a variety of methods for insulin delivery on the market, and some promising new developments on the horizon. These include:

1) Insulin pens. Most types of insulin are now available in convenient prefilled pens. Some insulin pens are entirely disposable when empty, and others use a replaceable insulin cartridge, usually containing 300 units. There is a dial on one end to set your desired dose. The pens offer discreet, push button insulin delivery. Some claim the injections are more comfortable than from a needle that has already been dulled by insertion into an insulin vial. Many people prefer to use an insulin pen if they are caring for a diabetic child or pet.

2) Insulin pumps. Insulin pumps are a device about the size of a pager that adhere to the skin and are worn 24/7. Insulin pumps contain an insulin reservoir, a battery powered pump, and a programmable computer chip that allows the user to control insulin dosing.

The pumps is attached to a thin plastic tube called a cannula, which is inserted just under the skin to deliver insulin subcutaneously and continuously. Insulin pump technology is constantly being improved upon. The newer pumps are smaller, and can "communicate" and interact with a continuous blood glucose monitor and computer software for state of the art blood sugar control.

3) Insulin jet injectors. Insulin jet injectors deliver a fine jet of high pressure insulin directly through the skin. The main advantage is that that the insulin delivery system requires no needles. The major disadvantage is that many diabetics find the force required for the insulin to permeate the skin is painful, and may cause bruising. Jet injectors have been on the market since 1979, but have yet to become popular.

4) Insulin patch. The FDA has just approved a new insulin delivery patch. The new device, Finesse, is a small plastic patch-pen roughly 2 inches long and an inch wide that is attached to the skin like a bandage. It can be worn under your clothes, and remains attached during routine activities like sleeping, exercising and even showering.

Patients use a syringe to pre-fill the patch-pen with a three-day supply of insulin, and simply push two buttons to dispense a dose of fast-acting insulin when needed. The insulin is delivered in seconds through a miniature, flexible plastic tube inserted painlessly into the skin. The manufacturer, Calibra is also working on a patch-pen that would deliver a .05 unit insulin dose for children.

5) Inhaled insulin. The FDA approved the first insulin inhaler, Exubera, in 2006. It was a short-acting insulin delivered to the lungs through a device similar to an asthma inhaler. But it never achieved market success, and was discontinued a year later.

But research on inhaled insulin continued, and two new forms are poised to hit the market. One is an insulin inhaler, AFREZZA, which is awaiting FDA approval. The other is an insulin spray which is absorbed through the mouth, called Oral-Lyn. Oral-Lyn is in Phase 111 clinical trials in Europe and North America.

Despite some obvious advantages to the new insulin delivery methods, tried and true insulin syringes remain the most popular way to deliver insulin injections with most insulin dependent diabetics, who no longer consider injections a big deal.

Insulin pens, insulin pumps, and insulin jet injectors are all more costly than insulin syringes, and not always covered by medical insurance.Not all types of insulin are available in insulin pens, and you can't mix insulin types in a pen.

Insulin pumps can kink or otherwise malfunction, posing the danger of inaccurate insulin dosing, and are just too "high tech" for some diabetics. Many diabetics remain skeptical of devices like insulin inhalers and sprays after Exubera's spectacular lack of success.

Still, with the advances being made in insulin pumps, and the pending introduction of an improved inhaled insulin and the insulin patch, the world of insulin therapy is definitely changing - and most would say for the better.

Mealtime Insulin Injections May be Replaced by an Insulin Inhaler

August 12th, 2011

There's good news for insulin dependent diabetics who rely on fast-acting mealtime insulin injections to keep their blood sugar under control. MannKind Corporation has the go-ahead to continue clinical testing of its investigational inhaled insulin, AFREZZA. The drug maker and the FDA met to confirm the protocols for two new studies, one in type 1 diabetics, and one in type 2 diabetics.

AFREZZA is an ultra-rapid acting inhaled insulin which uses patented 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 tennis court).MannKind focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes and cancer. Now in late stage clinical investigation, AFREEZA is its lead product candidate. Shares of the company jumped 20% at the news that the design of the follow-up clinical trials had been confirmed.

MannKind has been seeking approval for its new generation diabetes medication since March of 2009, but was asked twice to run additional clinical trials in order to provide the FDA with more information. One of the approval delays was due to the drug maker updating the design of its insulin inhaler after applying for approval of the earlier design. The FDA was concerned that there was not enough data to support a switch to the new generation device, and asked that both models be tested together.

Clinical trials of the initial design of the insulin inhaler were promising. Participants reported being pleased with the innovative insulin delivery device, and experienced less hypoglycemia and weight gain than did controls using a standard combination of long-acting insulin glargine and twice a day 70 30 insulin injections.

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. Because AFREEZA is a short-acting mealtime insulin, type 1 diabetics will need to combine it with long-acting insulin injections for complete diabetes control.

Dr. Larry Deeb, a pediatric endocrinologist from the University of Florida College of Medicine, says that failure to comply with regular insulin dosing is one of the major issues in diabetes, often because of the discomfort and inconvenience of insulin injections. Deeb says that finding an alternative insulin delivery method is crucial, especially for children and the needle-phobic.

Should it be approved, AFREEZA would be the second inhaled insulin to hit the market. Pfizer received approval to market a similar product, Exubera, several years ago, but, surprisingly, the product never caught on with diabetics, and was withdrawn from the market a year later.

AFREZZA is easier to use, faster acting and boasts better bioavailability than Exubera, enabling diabetics to achieve more satisfactory insulin levels using smaller amounts. Despite Exubera's unexpected failure, AFREEZA is expected to be a blockbuster diabetes drug when it becomes available.