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.