Less Exuberance About Exubera: Pfiser To Stop Selling Its Inhaled Insulin

There was a report in today’s New York Times Busines Day section (October 19, 2007) entitled “Pfiser to Stop Selling Diabetes Drug” written by Alex Berenson. Apparently, Pfiser announced yesterday that it would discontinue production of its inhaled insulin preparation Exubera. Sales of the “breakthrough” drug (that’s how it was hyped early on) were extraordinarily poor and one can only assume Pfiser felt it had a “dog” in its drug arsenal.

Why Exubera didn’t sell

Our research group at the University of Missouri participated in Pfiser studies of the drug tha led to its eventual FDA approval last year. We treated 8 teenagers with the drug for about 3 years. We found that the inhaled insulin worked about as well as injected insulin but were a bit surprised to find that our study patients were not all that excited about using an insulin inhaler 3-5 times a day instead of taking shots as many times a day. The inhaler was large and clumsy to use (certainly not “cool” to a teenager) and took much more time than just taking the insulin by injection. In adition, since the inhaled insulin was vey short-acting, all patients needed to take 1-2 injections of a long-acting insulin every day. So, they were still “stuck” taking shots even with the inhaled insulin. At the end of the study, based on our experience, we thought the drug, although effective and likely safe (there have been some ongoing concerns about long-term pulmonary effects), would not be a big seller. It did not help that FDA approval and subsequent availability of the drug were delayed at least 3-4 years after the studies were completed. It also hurt that the drug was not approved for patient under 18 years of age, very expensive, and not covered by many insurers.

What’s next?

I know that several other drug makers are currently planning to indroduce their own versions of inhaled insulin. I wounder if they will rethink their plans? I do hope at least one drug maker will offer inhaled insulin even if it is not a blockbuster; there are some patients who would benefit from the drug. For example, we often treat patients with type 1 diabetes with a single daily injection of a very long-acting insulin and injections of short-acting insulin with meals and snacks. Some patients really dislike the injections but are willing to take the long-acting shot and shots with each meal but they “fight” more shots with snacks- we encourage that such patients focus on 3 main meals and skip the snacks, except maybe with exercise. For such patients, inhaled insulin might be just the ticket if they really want a snack and still maintain blood sugar levels in line.

Probably more than anything, failure of the Pfiser inhaled insulin to make a big splash supports the notion that it’s not really the shots that people with diabetes dread most but it’s the whole difficult routine that is so hard to deal with.

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