Seeking to save diabetics from having to use needles for injecting insulin every day, some companies have tried to develop an inhalable form of insulin.
Pfizer, the world’s largest pharmaceutical company, announced last October that it would stop marketing Exubera, which had not sold very well. Pfizer had developed it in partnership with Nektar Therapeutics, a California drug company.
Work on developing an inhalable insulin has been going on since 1924, when the idea was first thought of by German researchers. The problem is that insulin is a large, complex protein and delivering it to the body via the lungs is a challenge. The size of the particles has to be reduced so small that it can reach the very tiny lung capillaries which would absorb it into the bloodstream.
Not until the 1990s did testing begin on humans and in January, 2006, the FDA approved Exubera for both Type 1 and Type 2 diabetes. Withdrawing Exubera so soon after it had been approved has cost Pfizer $2.8 billion.
With the FDA, Pfizer and Nektar had been reviewing data from the three FDA testing phases and the subsequent reports after Exubera went on the market. Exubera was causing breathing problems in many patients. The drug carried a warning label about this.
There was a problem about dosage, as Exubera is dosed in milligrams, but insulin is traditionally prescribed in international units. One mg of Exubera equals three units of insulin, so one would expect that three mg would equal nine units. But it doesn’t; it’s the equivalent of only eight units. Doctors were advised to refer to the company’s conversion table.
Exubera is a fast-acting insulin. Therefore it begins working in the body more quickly than injected insulin and works for a shorter time. So diabetics still needed injections of longer-acting insulin to keep the level steady each day.
Meanwhile, other companies are trying to develop their own forms of inhaled insulin, as the idea is a good one, and with diabetes on the upswing, could potentially be lucrative. The MannKind Corporation in California is working on one called Technosphere Insulin, which is in the final stage of FDA testing. Eli Lilly’s product has just completed Phase 2 testing. Novo Nordisk, a Danish company, is also investing large sums in inhalable insulin. Other companies have developed less painful needles for insulin injection.
In the long term, this is all good news for diabetics, as eventually there will probably be a painless and effective way to take insulin. Meanwhile, if you have been injured by Exubera, and are wondering if you might have a valid legal claim, please contact us for a free consultation.