July 02, 2014
3 min read

5 questions patients will ask about newly approved inhalable insulin

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In light of the recent FDA approval of the inhalable insulin powder Afrezza, Endocrine Today called on board member David S. H. Bell, MB, FACE, of Southside Endocrinology, Birmingham, Alabama and retired professor of medicine from the University of Alabama School of Medicine, to see what patients might want to know about the drug.

Afrezza (MannKind Corp.), an inhalable mealtime insulin, was demonstrated to effectively reduce postprandial Hb1Ac in combination with basal insulin. It is not the first inhalable insulin available to treat diabetes; Exubera (Pfizer) was approved by the FDA in January 2006. The packaging was updated in 2008 to reflect revised data showing increased lung cancer risk.

David S.H. Bell, MD, FACE, FACP

David S. H. Bell

Bell anticipated some questions patients may have as the drug moves toward production.

Top questions from patients

Q: If I smoke, can I use inhalable insulin?

A: No. Bell and the press statement from MannKind Corp. both urged that the drug should not be prescribed to smokers.

Q: If I have asthma, chronic obstructive pulmonary disease (COPD) or other chronic lung conditions, can I use Afrezza?

A: No. According to the press release, the Afrezza box will carry a warning stating, “Acute bronchospasm has been observed in patients with asthma and COPD using Afrezza. … Afrezza is contraindicated in patients with chronic lung disease such as asthma or COPD.” Physicians are urged to perform a detailed medical history, physical examination and spirometry to identify undiagnosed lung disease, the press release said.

Q: Do I need to pass a lung function test before starting the drug? Will lung function tests be required regularly during my use of this drug?

A: Yes, patients must pass a lung function test, and yes, these tests should be repeated at a regular interval to ensure normal lung function as advised by the package insert, according to Bell. The press release from MannKind Corp. recommends doctors “assess pulmonary function (e.g., spirometry) before initiating, after 6 months of therapy, and annually, even in the absence of pulmonary symptoms.”

Q: What are the side effects?

A: “The most common respiratory side effect experienced with Afrezza in trials was a mild, transient, non-productive cough. Discontinuation due to cough was uncommon,” a release from MannKind Corp. stated.

Q: How much will the drug cost?

A: “MannKind Corp. will finalize pricing in collaboration with their future marketing partner, but they anticipate that Afrezza will be priced comparably to rapid-acting analog pens,” a representative of the biopharmaceutical company told Endocrine Today.

The big question from physicians

Q: Does inhalable insulin therapy increase the risk for developing cancer?

A: A 2008 update to an earlier inhalable powdered insulin (Exubera, Pfizer) showed that the pharmaceutical company acknowledged that treatment resulted in increased occurrence of malignant lung cancer. The product’s packaging was updated to note that all patients who used Exubera and subsequently developed lung cancer had a history of cigarette smoking.

“Remember insulin is a growth factor. When you’re putting insulin into the lungs, it may well accelerate growth. Remember Exubera. Part of the reason everyone thought it would come off the market was because the device was big and awkward. But there may have been another reason, too; Pfizer showed there was an increased risk for cancer,” Bell said.


Bell said the packaging and device that delivers the powdered insulin is an improvement on the Exubera device. “It’s a nice little appliance.”

“We’ve had injectable insulin for 90 years. It has worked well,” he said. “Throughout the years we’ve experimented with insulin eye drops, nasal insulin, encapsulated oral insulin and even vaginal and anal suppositories. All of these things have never really worked out. Now, we’ve got a very convenient, painless system to administer insulin, especially with insulin pens and their 32-gauge needles. Frankly, I don’t see the need for this.” — by Reagan Copeland

For more information, see the press release upon FDA approval from MannKind Corp.

More about inhaled insulins on Healio.com

FDA approves Afrezza inhaled insulin for adults with diabetes

FDA advisory panel recommends approval for inhaled insulin

Inhaled insulin may be associated with lung cancer

Inhaled insulin improved glycemic control better than powder

FDA approves inhaled insulin for diabetes