Inhalable Insulin Could Be Coming Soon
If you have type 1 or type 2 diabetes and need to take insulin injections, you may dream of the day when the needles are a thing of the past. If all goes well, inhalable insulin could be coming soon, and you might be able to forget about those insulin jabs.
What’s the story on inhalable insulin?
MannKind Corporation has been conducting clinical trials on an inhalable insulin powder called Afrezza, which could eliminate the need for insulin injections for people with diabetes. If you are thinking, “Weren’t there inhalable insulin products available in the past?” you are right, but hopefully this time will be different.
You may remember back in 2005 there was an inhalable insulin called Exubera (Pzifer), but the product was withdrawn from the market in 2007, not because it was unsafe but because it didn’t help many patients and it was so costly insurers would not pay for it. Since then, several other pharmaceutical companies stopped their inhalable insulin research. (There is research, however, on insulin pills.)
MannKind, however, is betting it has a winner with Afrezza, an insulin human inhalation powder that is delivered via single-use cartridges and an inhaler (called the Dreamboat™ inhaler). The drug is designed to be used before a meal and delivers insulin so that peak levels are attained within 12 to 14 minutes.
Thus far, Afrezza has been evaluated in 61 different clinical studies that involved more than 5,600 adults with diabetes. Among them are two phase 3 clinical studies.
In Study 171, patients with type 1 diabetes were given either Afrezza or an injectable insulin. The researchers observed significantly less hypoglycemia, significant decreases in fasting blood sugar levels, important declines in hemoglobin A1c levels, and significant weight benefits (i.e., less weight gain than that associated with other insulin treatments) with use of Afrezza compared with traditionally administered insulin.
In Study 175, patients with type 2 diabetes were given either Afrezza or antidiabetes oral therapy only. Those who took Afrezza showed superior declines in their hemoglobin A1c levels, with more patients reaching target A1c goals.
The positive results researchers achieved in these two phase 3 trials will be included in the company’s new drug application to the Food and Drug Administration later in 2013, according to Alfred Mann, chairman and chief executive officer of MannKind Corporation. Afrezza is estimated to cost about $2,000 per year.
According to the Afrezza website, the most common side effects observed during the clinical trials were hypoglycemia (abnormally low blood sugar levels) and mild, temporary, non-productive cough. The maker of Afrezza noted that the inhalable insulin “has the potential to change diabetes therapy by offering significant benefits to the growing population of patients with diabetes.”