Needle-free Insulin

Needle-Free Insulin
(The Washington Post, August 21, 2001)

The only way for diabetics to get insulin into their bloodstream is to inject it or wear a pump that infuses it through the skin via a catheter. The challenge: Find an easier way.

WHY BOTHER? People with diabetes are more likely to comply with a more convenient, less painful regimen, which would mean greater protection from such devastating disease complications as blindness, kidney failure and nerve damage. A breakthrough could eliminate needles for many of the country's 15 million type 2 diabetics (whose bodies produce insulin but can't use it properly) and reduce needles for the 1 million Americans with type 1 diabetes (in which the pancreas makes little or no insulin).

BIG IDEA ONE: Inhale it. Exubera, a dry-powder form of insulin, is inhaled before meals with a special device similar to an asthma inhaler. In a study of 299 patients with type 2 diabetes, Exubera normalized blood sugar levels as well as injections did. More patients who used Exubera were able to achieve good overall blood sugar control (47 percent) than were those who took multiple shots (32 percent). Patients taking inhaled insulin also reported greater satisfaction and quality of life.

Problem. About one in five study subjects developed a mild cough with inhaled insulin, and a few reportedly developed more serious lung problems. It's not certain that the serious problems are related to the inhaled insulin, but the manufacturers will have to convince the Food and Drug Administration (FDA) of the product's safety before it can go to market. They'll also have to prove that the device can deliver insulin consistently and reliably.

Forecast. Co-developers Aventis, Pfizer and Inhale Therapeutic Systems plan to apply for Exubera's approval with the FDA by year's end. If all goes well, the product could be on the market in a year or two.

BIG IDEA TWO: Spray it in your mouth. Oralin, an aerosolized insulin absorbed through the cheeks and into the bloodstream, lowered blood sugar as effectively as pre-meal injections in a preliminary study. It also proved powerful when used in combination with other diabetes drugs in patients with type 2 diabetes. Oralin is not inhaled so it shouldn't affect the lungs. Toronto-based Generex Biotechnology Corp. makes Oralin in cooperation with Eli Lilly.

Problems. None reported so far in manufacturer-sponsored trials. But just as with inhaled insulin, the company will have to prove that its spraying device -- called RapidMist -- will deliver the right insulin dose every time.

Forecast. Could reach the U.S. market by 2005.

BIG IDEA THREE: Swallow it. Insulin is broken down in the digestive tract, which has made its oral ingestion impossible in the past. But a new pill formed by attaching inert polymers to the insulin molecule appears able to pass through the stomach intact and normalize blood sugar levels in patients with type 1 and type 2 diabetes, report researchers at three institutions, including Georgetown University.

Because the pill gets insulin straight to the liver, mimicking the process in a non-diabetic's body, studies suggest it may offer an advantage over injected insulin: reducing the number of dangerous low blood sugar episodes and other possible risks from excess insulin coursing through the patient's body tissues.

The compound is made by Nobex Corp. of Research Triangle Park, N.C.

Problem. This compound has a way to go to prove its mettle. In particular, the company will have to show that the polymerized insulin doesn't adversely provoke patients' immune systems. And attempts to make a liquid formulation for children have hit a snag: The stuff tastes awful.

Forecast. Market-ready in 2005, at the earliest. ###

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