Pfizer, and its partner Sanofi-Aventis, have filed an application with the U.S. Food and Drug Administration (FDA) to market their inhaled insulin formula, Exubera, in the United States. Exubera is a dry, powdered form of insulin, that is inhaled into the lungs via a special inhaler, and from there absorbed into the bloodstream. Exubera, which was developed by Nektar Therapeutics, is intended for use by any insulin-using diabetic, type 1 or type 2. The European Medicines Evaluation Agency is also reveiwing the drug, for possible licensing in the European Union.
Eli Lilly is also working on an inhaled insulin, the Lilly/Alkermes Inhaled Insulin System. Currently in Phase II clinicals, Lilly researchers are tackling the problem of "duration of effect," the fact that inhaled medications tend to work, but "all-at-once," quickly and with a pronounced peak. Per their reported data, outcomes are good; they are solving the problem, and achieving results similar to those from injectable insulin.
Canada-based Generex Biotechnology has published studies, carried out in Israel, of its Oral-Lyn insulin, detailing that formulation's success. Oral-Lyn goes in the mouth, yes, but it is not, like the others, an "inhaled" insulin -- it is absorbed by the mucosa of the mouth, not the lungs. Oral-Lyn is in clinicals in a number of locations, and, the company reports, doing well.
None of these inhaled insulins are ready for market; all could go the distance
and be approved. Any, or all, on the other hand, could fail the FDA's safety
tests. They are all works-in-progress. Stay tuned, Voice of the Diabetic
will keep you posted when it looks like the first one nears the finish line.
For now, it's a horserace, and they're all running strongly.