Research and Development summary

Inhaled insulin safe for smokers

INHALED insulin is safe and effective in smokers and non-smokers, researchers say.

Data presented at the 61st Annual American Diabetes Association meeting in Philadelphia, Pennsylvania, confirmed that pulmonary absorption of insulin is enhanced in smokers compared with non-smokers. However, both smokers and non-smokers tolerated the pulmonary insulin equally well.

The study, conducted in 43 healthy volunteers of whom 27 were smokers, assessed AERx, the inhaled insulin system, being developed by NovoNordisk and Aradigm. Dr Peter Damsbo, head of clinical drug development for NovoNordisk commented that further studies were needed to understand the factors in smoking that affected pulmonary absorption of insulin but added: “Because smokers absorb more of the inhaled insulin, they may require lower doses than non-smokers.”

Three groups are in the race to market the first inhaled insulin. In addition to the NovoNordisk/Aradigm system, Pfizer in collaboration with Aventis Pharma and Inhale Therapeutics and Lilly in collaboration with Akermes are also developing inhaled insulin products. In May, the Aventis group said that it planned to file for regulatory approval of its product, Exubera, later this year (PJ, 26 May, p708).

However, there is ongoing debate over the safety of inhaled insulin, particularly as much larger doses are needed than when inhaled insulin is given by injection. At an Aventis research and development meeting in May, the company reported that one patient out of 1,000 treated with the drug had developed pulmonary fibrosis while using Exubera.

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