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On October 18, 2007, Pfizer announced that it is returning its EXUBERA rights to Nektar Therapuetics and that it would continue to make EXUBERA available for three months, until January 16, 2008, to help physicians and their transition off EXUBERA and onto other glucose lowering therapies.
However, Pfizer recognizes that some patients may need EXUBERA for a additional period of time. Therefore, as of January 16, 2008, Pfizer is making an Extended Transition Program (ETP) available for qualified patients free of charge for a limited time.
In an ongoing review of Pfizer's (now discontinued) inhaled insulin (Exubera), an increased chance of lung cancer has turned up among participants in the clinical trials. Six of the over four thousand patients in the trials on Exubera have since developed the disease, versus one of the similarly-sized control group. Six isn't many, but with that large a sample size, it's something that statistically can't be ignored, either.
The FDA is going to be very, very cautious about allowing any sort of inhaled insulin trials to proceed. I’d think that you’d have to show that your product is different from Exubera in its carcinogenic risk just to get one off the ground, and frankly, I have no idea how you’d do that. Anything that could will take years to develop and validate.