Afreeza-Inhaled Insulin for Type 2 Diabetes

Could This Be the End of Insulin Injections?

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If you have Type 1 or Type 2 diabetes and are tired of taking multiple daily insulin injections, you'll be happy to hear that the Food and Drug Administration has just approved a new inhaled insulin, Afreeza. Afreeza is a powdered fast-acting insulin, created to help reduce meal-time blood sugars. It is unclear when it will hit the market, because it is required to undergo post-marketing studies such as, efficacy and safety in pediatric patients, potential risk for lung cancer, and other studies to characterize dose-response and variability from person to person.

Nonetheless, advancements in diabetes medicines continue to make headlines with the hopes of improving the care of this difficult disease. Because diabetes is a disease that needs to be managed on a daily basis, improvements in care rely heavily on simplifying treatment plans. Patients have difficulty being successful when they feel as though they are on rigorous medication regimens. Throughout the course of my career, I have learned that simplifying treatment plans is critical and can truly impact self care behaviors and outcomes. I would imagine that those people making and marketing the insulin hope and believe that this innovation will help to make diabetes more manageable.

But, the problem is that this isn't the first time we have tried to use an inhaled insulin. Back in 2006, the FDA approved the first ever inhaled insulin, Exubera. Unfortunately, the powdered insulin had poor sales and was taken off the market shortly after launching in October 2007, costing Phizer 2.8 billion dollars.

This product failed for several reasons: 1) a cumbersome and inconvenient delivery system, 2) the inability to change the dose of insulin, 3) potential risk of lung problems, 4) a big out of pocket expense to patients.

What is The New Inhaled Insulin, Afreeza?

Afreeza, which is manufactured by MannKind Corp, is a rapid-acting inhaled human insulin that should be used at the beginning of each meal.

Afreeza does not replace long-acting or basal insulin and needs to be used in conjunction with a basal insulin for those patients with Type 1 diabetes. According to MannKind, Afreeza Inhalation Powder is delivered using a small, discreet and easy-to-use inhaler. Afreeza dissolves rapidly upon inhalation to the deep lung and delivers insulin quickly to the bloodstream. Peak insulin levels are achieved much more rapidly than other meal time in insulin, within 12 to 15 minutes of administration, and decline to baseline by approximately 180 minutes.

Is it Better Than Other Fast Acting Insulins?

Studies conducted in patients with Type 1 diabetes have shown that Afreeza is noninferior to Aspart (another fast acting insulin) in terms of Hemoglobin A1c reduction, but it did not reduce Hemoglobin A1c as much as Aspart. What this means is that a non-inferiority trial aims to demonstrate that the test product is not worse than the comparator by more than a small pre-specified amount or in other words, a fancy way of saying, "just a little bit worse." When tested in those patients with Type 2 diabetes on oral diabetes medicines, patients taking Afreeza and oral diabetes medicines reduced A1c significantly as compared to those taking a placebo and oral diabetes medicines.

This makes sense that those patients taking insulin as compared to a placebo would have better blood sugar. There is some research that indicates less chance of hypoglycemia when using Afreeza.

How Will Afreeza Be Different Than Exubera?

The Afreeza delivery device is set to be less cumbersome than that of Exubera. It is also expected to be more compact and easier to use. Exubera was dosed base on body weight and the dose could not be changed. Afreeza will be dosed using a unit measurement-the same way we dose insulin.

How Does Afreeza Work?

The powder is inhaled at the start of a meal sending, microparticles into the lungs, which once dissolved releases insulin at a much faster rate than other fast acting insulin. It has been referred to as an "ultra-rapid-acting-insulin."

Are There Side Effects?

Like all medicines, there are potential side effects. Most common side effects are the risk of hypoglycemia (a side effect when taking any insulin), cough and throat irritation. Boxed warning on label read: Acute bronchospasm has been observed with Afreeza use in patients with COPD/asthma. Afreeza is not meant to treat diabetic ketoacidosis and should not be used in patients who smoke, have lung disease, asthma or COPD.

Is There a Market?

Diabetes is an extremely individual disease - what works for one person may not work for another. While some people don't mind insulin injections because the needles are short and thin and insulin pens are easy to carry, others simply forget to take their insulin, hate bringing pens to public places and injecting themselves. If delivered correctly, Afreeza may be a good alternative to multiple daily injections for those persons in need of meal time insulin.

Resources:

Weintrabu, Arlene. Technology. Pfizer's Exuber Flop. Accessed on-line. July 23, 2014: http://www.businessweek.com/stories/2007-10-18/pfizers-exubera-flopbusinessweek-business-news-stock-market-and-financial-advice

Food and Drug Administration. FDA Approves Afreeza to Treat Diabetes. Accessed on-line. July 24, 2014: http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm403122.htm

Berg, Erika. What's Next for Insulin. Accessed on-line. July 24, 2014: http://www.diabetesforecast.org/2014/05-may/whats-next-for-insulin-no.html

Mannkind Corp. Afreeza - A First-in-Class Ultra Rapid Acting Insulin. Accessed on-line. July 24, 2014: http://www.mannkindcorp.com/product-pipeline-diabetes-afrezza.htm

Food and Drug Administration. FDA Approves Afreeza to Treat Diabetes. Accessed on-line. July 23, 2014: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm403122.htm

MannKind Corp. MannKind Corporation Announces FDA Approval of AFREZZA(R); A Novel, Rapid-Acting Inhaled Insulin for the Treatment of Diabetes. Accessed on-line. July 26, 2014: http://www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1943390&highlight=





 

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