Brand name: Afrezza Inhalation Powder
Generic: Insulin human
Medication Class: Human insulin (rDNA origin)
Similar drugs: NovoLog (Insulin Aspart), Humalog (Insulin Lispro) and Apidra (Insulin Glulisine)
Manufacturer: MannKind Corporation
Approval Date: June 27, 2014
What is Afrezza and how does it work?
Afrezza is a newly approved man-made insulin. It is unique because it is the only insulin that is available as an inhalation powder. Upon inhalation, the insulin powder is quickly absorbed from the lungs into the blood stream. Like other insulins, Afrezza regulates blood glucose (sugar) by reducing the amount of glucose produced by the liver, as well as increasing uptake of glucose by cells. This causes blood glucose levels to fall. Insulin is a natural hormone that is produced by the beta cells of the pancreas. Beta cells release insulin to help the body use glucose that comes from food. In type 1 diabetics, beta cells do not work properly, therefore, the pancreas cannot produce insulin. In type 2 diabetics, the pancreas may be able to make insulin but their cells do not respond well to it due to insulin resistance. This is the reason why type 1 diabetics and some type 2 diabetics need to inject themselves with insulin.
Afrezza is a rapid-acting insulin. It reaches peak levels within 12 to 15 minutes of use. The median time to reach the maximum effect is about 53 minutes and the effect lasts about 160 minutes (2 hours). The metabolism and elimination of Afrezza are comparable to that of regular human insulin. The half-life (the amount of time it takes for the concentration or amount of a drug to be reduced by half) is 28 to 39 minutes.
After inhalation of Afrezza, 39% of carrier particles are distributed to the lungs, while 7% is swallowed. The carrier particles are not metabolized and are eliminated unchanged in urine. The swallowed portion is not absorbed in the gastrointestinal tract and is eliminated unchanged in the feces.
What is Afrezza used to treat?
Afrezza is used to control hyperglycemia (high blood sugar) and improve glycemic control in adults with type 1 or type 2 diabetes mellitus.
How effective is Afrezza?
A clinical study of 3,017 adults (1,026 type 1 and 1,991 type 2 diabetics) tested how well Afrezza works. The average duration of treatment was 8.17 months for the general population, 8.16 months for type 1 diabetics and 8.18 months for type 2 diabetics.
In type 1 diabetics, Afrezza was compared to insulin aspart in combination with a long-acting insulin. Over a treatment period of 24 weeks, type 1 diabetics using Afrezza had a smaller reduction in HbA1c (hemoglobin A1c, a way to measure of blood sugar control) compared to those using insulin aspart. There was a 0.21% HbA1c reduction with Afrezza compared to 0.40% in those using insulin aspart. More patients taking insulin aspart reached the HbA1c target of 7 or lower; 27.1% of patients taking insulin aspart reached this target compared to 13.8% using Afrezza. Both sets of patients were also using a long-acting insulin during the treatment period.
Afrezza was also studied in adults with type 2 diabetes. In this study, Afrezza was compared to a placebo (inhaled powder not containing insulin) in combination with oral antidiabetic drugs. Patients that were selected were those whose diabetes was not well controlled while taking an ideal or maximum dose of metformin only, or taking 2 or more oral antidiabetic drugs. After 24 weeks of treatment, the patients using Afrezza plus oral antidiabetic drugs had a higher reduction in HbA1c reduction compared to those using the placebo inhaler and taking oral antidiabetic drugs; 0.82% HbA1c reduction on Afrezza compared to 0.42% reduction on placebo.
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