Voice of the Diabetic

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INHALED INSULIN UPDATE

by Peter J. Nebergall, PhD

Photo: portrait. Caption: Peter J. Nebergall

In VOICE Volume 13, No. 4, I reviewed the surprising development of inhaled

insulin, insulin taken into the lungs instead of injected beneath the skin.

At that time I explained that inhaled insulin works, you do get blood glucose

reduction, but the problem has been to moderate the dose, so as to allow consistency

and reduce chance of hypoglycemia.

Research has continued, following several lines of inquiry. Inhale Therapeutics,

of San Carlos, California, has developed both an aerosol-type inhaler device

and a technique of micro-encapsulating insulin that allows it to penetrate deeply

into the lungs. Their delivery system, and the special dry-powder insulin it

requires, are currently in Phase III clinicals.

On December 15, 1999, Inhale Therapeutics was issued U.S. Patent No. 5997848,

for their method of delivering inhaled insulin. One should note that their proprietary

"deep-lung" delivery technique should function with a variety of (previously

injection-only) medications, and that the syringe's days may be numbered.

On June 14, 2000, the company reported on new data provided by its manufacturing

partners Pfizer and Aventis Pharma, who have been testing the inhaleable insulin

they manufacture on patients for the last 30 months. The data showed HbA1c results

remained stable across the test period, and that long-term use of inhaled insulin

did not pose any "black-lung" type threat to the lungs.

How are they doing? There are a lot of hoops to jump through, on the way to

getting a new medication accepted by the Food and Drug Administration. It can

take years. Inhale has come a long way. They have a patent. They may well succeed

-- but they aren't there yet.

Andaris, the competing British firm mentioned in my earlier article, has been

purchased by Quadrant Healthcare PLC, with the new "Quadrant Group" focusing

on inhaled and orally-delivered pharmaceuticals of all types. Watch for them.

California-based Aradigm Corporation is another player, and their AERx oral

insulin administration system is currently in Phase II clinicals. Aradigm claims

their product, which produces a fine aerosol mist, produces glucose control

comparable with a dose of Regular insulin taken 30 minutes before mealtime.

Data to support this assertion were presented at the 2000 annual meeting of

the American Diabetes Association.

UK-based Provalis PLC, a subsidiary of Cortecs International, is following

a different path, working to develop Macrulin, an oral, rather than inhaled

insulin formulation, one that can pass through the digestive tract and "go active"

in the intestines. Data appear promising, but Provalis is being circumspect

with the release of information, and will say only: "More news about Macrulin

will be released in late 2000."

There are many other players. Whoever is first to develop a reliable alternative

to injected insulin will be able to cash in big time, for the demand will be

tremendous.

When will it happen? Frank Vinicor, MD, MPH, Director of the Division of Diabetes

Translation at the Centers for Disease Control, speaking at the 1999 annual

meeting of the Diabetes Action Network in Atlanta, Georgia, stated: "I suspect

within a year or two, you'll see major studies, and probably within three years

or so you'll begin to see some availability. There are very practical issues

to work out ... but the initial results are very positive."

Stay tuned.

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