Pfizer/Nektar inhaled insulin brand Exubera was approved by the FDA in 2006 and market failure of the drug resulted in market withdrawal by Pfizer due to poor sales, difficulties in dosing, higher prices. There were safety issues as some patients developed lung cancer. The market failure after investment of over 2 billion dollars by Pfizer in 2007 resulted in bail out of many rival R&D projects. Only 1 other inhaled insulin (Afrezza) from MannKind was filed for the FDA approval in 2009. In March 2010, the FDA asked for more information about the drug and the inhaler to be used. A panel of diabetes experts of the FDA advisory committee may be consulted about the safety and efficacy of the drug. Long term effect on lung functions are not known. Loss of sensory perceptions
may be a problem with the Afrezza as well.

I actually disagree with Dr Mahboob. I think it is unlikely it will ever become a product.

Inhaled insulin used to have agreat strategy: find the patients with type 2 diabetes not doing well on oral agents and switch them to inhaled insulin before they were able to overcome their fear of injection pain.

There were several holes in that strategy. First, the major reason that patients did not want to switch to insulin was not the pain of injection (which accounted for only 27% fo the fear), but rather that they were actually "sick" if they needed insulin and that insulin was a hassle with all of the work in injecting and monitoring glucose. Exubera failed because it did not overcome the "being sick" and was more of a hassle than injecting.

Several things have happened to make a successful launch of a pulmonary insulin even less likely. First, many patients now go onto Byetta, Victosa etc before going onto insulin and realize that the pain and hassle associated with injection with pens and sharp fresh pen needles is virtually none. Second, the pain of lancing has similary gone to almost zero and finally the withdrawal of Exubera from the market, with a 4-8 billion dollar loss makes other pharma companies wary of the area.

A successful launch of Affressa will depand on several factors. First that the claim that no titration is necessary along with little of no blood glucsose monitoring is proved to be true in actual clinical practice and second that Mannkind can find the financing or work out a deal to do a successful large launch.