Inhaled insulin approved as diabetes treatment option

The powdered insulin is fast-acting and intended for mealtime use. Studies on long-term lung safety will continue.

By Susan J. Landers, AMNews staff. Feb. 20, 2006.

Washington -- Physicians welcomed the Food and Drug Administration's approval Jan. 27 of inhaled insulin, particularly for those patients with poor glycemic control who are unwilling to accept several daily insulin injections.

However, the inhaled insulin, which will be marketed as Exubera, isn't for everyone. It was approved only for those older than 18 and should not be prescribed for current smokers, for those who have smoked in the last six months or for patients with underlying lung disease.

Its long-term pulmonary effects are unclear. The drug's manufacturer, Pfizer, is continuing to follow 5,000 patients on Exubera over the next five years to see whether they experience any significant decrease in lung function over time. Minor decreases were seen among some of the patients in the clinical trial.

Nevertheless, a large portion of the 5 million people who use insulin may be able to switch at least some of their injections to a puff, or several puffs, from an inhaler. Exubera is being hailed as the first new delivery option since the discovery of insulin in the 1920s.

Diabetes affects nearly 21 million Americans, or 7% of the population, and another 41 million people are thought to have pre-diabetes, which increases the risk of developing type 2 diabetes, according to the Centers for Disease Control and Prevention.

Exubera is a fast-acting insulin that reaches peak concentration more quickly than some injectable insulin. It should be taken 10 minutes before meals, according to Pfizer.