Last Friday the FDA (US Food and Drug Administration) approved the latest inhaled insulin, Afrezza. I can remember a few years back the inhaled insulin Exubera was approved and then later pulled from the market due to safety concerns regarding lung tissue. I can remember my patients being so excited and then bummed when it was discontinued.
Afrezza is an ultra-rapid acting mealtime insulin approved for adults with type 1 and type 2 diabetes. It comes with a cartridge of the inhalation powder and then a very tiny inhaler. I can remember the Exubera inhalers were large chambers that would draw some attention if pulled out in a restaurant. This little inhaler looks a little smaller than the size of an asthma inhaler. Afrezza dissolves immediately after inhaling and then peaks at 12-15 minutes after being absorbed into the bloodstream.
The MannKind Corporation page for Afrezza reports that there have been clinical trials with over 6,500 patients, and the results have found reductions in hemoglobin A1cs, hypoglycemia and weight gain in comparison to rapid-acting insulin. They found that there were some small changes in lung function and did not continue with Afrezza was stopped. The most common side effect was a cough.
According to the FDA, studies have been done to compare Afrezza to insulin aspart and found that the HbA1c reductions were lower in aspart than Afrezza. They also of course caution that Afrezza is not a substitute for long-acting insulin and is not recommended for the treatment of DKA or in patients who smoke, have chronic lung diseases like COPD or asthma. The FDA also notes other common side effects of hypoglycemia and throat irritation. Studies are being conducted now to evaluate Afrezza in children and to see if using Afrezza increases cardiovascular risks and lung cancer.
When new products come out like this, it’s great to be the first ones to tell our patients so we can educate them on the pros and cons and how to correctly use products. I’m sure we will be hearing a lot more about this soon!