On January 27, 2006, the US Food and Drug Administration granted approval to drug manufacturer Pfizer, Inc., to market its Exubera inhalable insulin in the United States. This is a first. Pfizer won the race, but it’s not that kind of competition. Others are hot on their heels; and we WILL see competition in the field. But for now, we really do have an inhaled alternative to injectable insulin.
What do we know about it? It’s a rapid-acting insulin, with a response curve similar to Humalog. Its inhaler is somewhat bulky, hardly as “convenient” as an insulin pen, but it works—and for people who really can’t get used to needles, or have medical issues exacerbated by frequent needle sticks, Exubera is going to be a big help.
Who can take it? Adult insulin-using diabetics (it hasn’t been tested in children yet) who do not have lung disease, and who do not smoke and have not smoked for some time. Also, Exubera users should have their lungs checked before starting the medication, and regularly six to twelve months thereafter.
Will Exubera eliminate needles? No. People will still need to test their blood regularly with a finger-stick (and use of a quick-acting insulin like Exubera or Humalog requires a more vigilant blood testing program), and a lot of type 1 diabetics will still need to inject a slower insulin: NPH or Lantus.
Some insulin-using type 2s should be able to make the switch. Some type 2s, who really should be using insulin, but aren’t, because they don’t like needles, will be able to start insulin therapy and improve their self-management.
It won’t be long before Pfizer’s competitors arrive at the post with inhaled insulins of their own. Canada’s Generex has its Oral-lyn inhaled insulin in several clinical trials, including at least one to measure its efficacy and safety in diabetic children. Novo Nordisk, Eli Lilly, MannKind, and Kos Pharmaceuticals are also reported as working on inhaled insulins. Stay tuned!