Mannkind Corporation, a biopharmaceutical company in Danbury, Connecticut, will be releasing a new and easier daily treatment for diabetes within the next year.
Afrezza is an inhaler for diabetics used seconds before a meal. It allows an insulin powder to be absorbed into the bloodstream through the lungs, thereby replacing the insulin pills or injections most patients must take almost an hour before eating to control dangerous spikes in blood sugar level.
Afrezza may cause itching at the back of the throat initially, but it will not continue if the product is used regularly. Those with asthma, Chronic Obstructive Pulmonary Disease, and smokers are advised not to use Afrezza. It has been proven safe for adults 18 years and older.
“Hopefully, we can slow down the progression of the disease,” said Hakan Edftrom, President of Mannkind Corporation, in a phone interview.
One advantage to using Afrezza over current diabetes treatments is that the insulin hits the bloodstream within 15 to 20 minutes, whereas current treatments force the patient to wait up to an hour before being able to eat. Since it is so easy to use, patients are more likely to always use their treatment.
“With our product, you can take your inhalation as you sit down to a meal,” said Edftrom.
Afrezza also moves insulin out of the blood faster as well; the insulin is gone after three hours. With injected insulin, it remains in the body for too long, which can cause hypoglycemia, or low blood sugar levels.
A two year study involving 5,300 adult patients in 56 various studies was conducted on the drug. The outcome was very positive and improved the outlook of how patients lived with diabetes.
Once Afrezza and its data are submitted to the Food and Drug Administration (FDA) it will take about six months to be reviewed. Afrezza should be approved by the second quarter of 2014.
“What we are studying is the [ethics] and safety of the product,” said Edftrom.
Afrezza will hold a high level of competition when it reveals itself; it will cost just as much as an insulin pen.
Jenny Nichols, a type 2 diabetes patient of three years, feels like Afrezza could make a positive difference in how she keeps her diabetes under control. Currently, she is taking oral medication before meals, but she is impressed by Afrezza’s quick-acting insulin.
Scheduling her meals around the pill is something Nichols constantly battles with.
“I’ll take the pill and all of a sudden it’s 45 minutes later,” Nichols said in a phone interview.
Especially when eating at restaurants, it can be frustrating to have to manage the medication in the middle of a busy dining room.
“There’s a lot of social stigma attached,” said Nichols.
Hypoglycemia is a condition that many people, diabetic or not, experience everyday. The National Diabetes Information Clearinghouse informs that the condition is when there are low levels of sugar, or glucose, in the blood. Glucose is used in the body for energy and is found in carbohydrates such as rice, potatoes, bread, and cereal.
After food is ingested, the glucose from the food is absorbed into the bloodstream, and as the pancreas releases insulin, glucose is utilized. Excess glucose is stored in the liver as glycogen for energy between meal times and stored as fat for energy as well.
Symptoms of hypoglycemia include hunger, shakiness, and anxiety.
The American Diabetes Association explains that Type 1 diabetes, when the body doesn’t produce insulin, usually affects children and young adults. Type 2 diabetes is more common and is marked by low insulin production or by cells that simply ignore insulin and do not use it.
Type 2 is most prevalent in African Americans, Native Americans, Asian Americans, Native Hawaiians, and the elderly.
About one in every 400 children and adolescents has diabetes and 25.6 million people 20 years and older have diabetes. Additionally, there are 10.9 million people 65 years old and older who have diabetes.
Edftrom is very anxious for Afrezza to officially make its way into the world of modern medicine. Once Afrezza and its data are submitted to the Food and Drug Administration (FDA) it will take about six months to be reviewed. Afrezza should be approved by the second quarter of 2014.
In the future, an Afrezza-like product could be used for more than just diabetes treatment. The concept of Afrezza can be applied to other conditions, such as migraines. Since the inhaler allows medication to be absorbed into the bloodstream so quickly, it is effective and easy to use for many medical needs that require a quick signal response.
The employees at Mannkind have been heavily involved in the production of Afrezza. There was also some work completed for the project in the corporation’s other locations: Paramus, New Jersey, and at headquarters in Valencia, California. There have been a total of about 250 people who have taken part in creating Afrezza.
“This is a very, very significant step forward,” said Edftrom.