Inhaled Insulin Afrezza: FAQ
The drug will carry a warning that it could cause sudden tightening of the chest, known as acute bronchospasm.
It is not recommended for people with asthma or COPD, or in smokers. It isn't recommended to treat diabetic ketoacidosis, a serious complication when the body makes high levels of blood acids known as ketones.
The FDA is also requiring further study to evaluate the potential risk of lung cancer.
Is this a game-changer for people with diabetes?
Some experts think so, but others are taking a wait-and-see approach.
"I think it is," Campbell says. He says the inhaler for Afrezza is better designed and easier to use than a more cumbersome one used with another inhaled insulin, Exubera, he says.
Exubera was approved by the FDA in 2006 but withdrawn from the market by its maker, Pfizer, in 2007, in part due to low sales.
Health care providers had to spend a half hour or so just to explain how to use the Exubera inhaler, Campbell says. The Afrezza inhaler, he says, ''is really small, easy to use, and it takes less than a minute to train a patient how to use the insulin."
Marie McDonnell, MD, director of the Brigham Diabetes Program at Brigham and Women's Hospital, says Afrezza has promise if "we can show there is no risk to the lung tissue and the mouth and esophagus."
"It works faster than both of the injected insulins we have now, the regular and the rapid-acting," she says. "This might mean you will need less insulin [overall] to get the same effects." And that may lessen the weight gain that often occurs in new users, she says.
She plans to prescribe it, but on a case-by-case basis.
George King, MD, chief scientific officer at Joslin Diabetes Center, says it may be helpful for some. "I think inhaled insulin would be good for people who are really adverse to needles," he says. But he estimates only 10% or 15% of people on insulin fit that category.
What will it cost?
"Our expectation is it should be priced comparably to current fast-acting [injected] insulins delivered in pen form," says Matthew Pfeffer, a MannKind spokesman.
Prices for the fast-acting insulin pens vary. One popular fast-acting pen insulin costs about $270 a month, without insurance coverage, for a person who needs 30 units a day, a common amount.
When will it be available?
That is not certain. MannKind is seeking to partner with a pharmaceutical company for distribution, Pfeffer says.