This is interesting. I had not heard that you could deliver insulin in a nebulized / aerosolized form. Intriguing. Pulmonary insulin delivery – which products will triumph?
The big companies currently pioneering pulmonary delivery of insulin are Pfizer, Eli Lilly/Alkermes and Novo Nordisk/Aradigm.Leading the pack is Exubera, which Pfizer now owns after buying the rights off Sanofi-Aventis for $1.3 bn this month.
Exubera is a fast-acting powdered insulin that is inhaled into the lungs before each meal, using a device the size of a torch. Both the formulation and device were developed by Nektar Therapeutics.
With a 2–3 year lead on other such products in clinical development, Exubera should make it to the market first, proving to be a sure-fire blockbuster for Pfizer.
In clinical trials Exubera was as effective as injected insulin, however, it has been shown to cause a short-term decrease in lung function and concerns over the long-term affect of inhaling insulin into the lungs has led to ongoing delays in US Food and Drug Administration (FDA) approval of the product.
In September 2005, an FDA Advisory Committee finally recommended approval of Exubera for the treatment of adults with type 1 (insulin-dependent) and Type 2 diabetes (non-insulin-dependent).
However, in October, the FDA extended its original review period of the drug by three months while it considers additional data submitted on its potential to decrease users’ lung capacity.
More on Exubera, it’s a “an inhaled, rapid-acting, dry-powder insulin”, and more about the Nektar delivery device. And this is what it looks like.
Update: LA Times Article on Exubera.