The U.S. Food and Drug Administration on June 28, 2014 announced the approval of Afrezza, an inhaled insulin used in the treatment of diabetes. The rapid-acting medicine can be used at the beginning of a meal or within 20 minutes after the start of a meal to control glycemic levels in adults with diabetes, according to the UPI article, "Inhaled insulin approved by FDA." This new, quick acting insulin inhaler uses a powder (AFREZZA™) to deliver the medication. The quick acting insulin inhaler uses a powder that's equivalent in size to a pinch of salt.
Who the drug, AFREZZA™ is aimed at are patients with diabetes who need to take insulin at mealtime. Back in 2010 researchers presented their study at the 239th American Chemical Society national meeting in San Francisco when the research team discussed AFREZZA™, according to the March 23, 2010 news release, "New form of insulin can be inhaled rather than injected."
Scientists on March 23, 2010 described a new ultra-rapid acting mealtime insulin (AFREZZA™) that is orally inhaled for absorption via the lung. Because the insulin is absorbed so rapidly, AFREZZA's profile closely mimics the normal early insulin response seen in healthy individuals. Since 2010 AFREZZA had been awaiting approval by the U. S. Food and Drug Administration (FDA), which it finally received on June 28, 2014.
Researchers gave their presentation about the drug at the 239th American Chemical Society National Meeting, held in March of 2010. Andrea Leone-Bay, Ph.D. and colleagues at MannKind Corporation at that meeting several years ago, said that the new insulin product, uses the Technosphere® technology, a delivery technology that is applicable to a wide variety of other drugs that are currently injected. Like insulin, these medications are proteins that would be digested and destroyed in the stomach if taken by mouth.
One such product, MKC-180, is a Technosphere® formulation of a natural hormone that controls appetite and at the time of the 2010 meeting was said to be under investigation as a therapy for obesity using pulmonary delivery. "In nonclinical studies remarkable reductions in food intake have been observed," Leone-Bay said, according to the news release, "New form of insulin can be inhaled rather than injected." MannKind Corporation at the time of the 2010 meeting also was evaluating Technosphere® technology with drugs that treat pain and osteoporosis.
"Our proprietary Technosphere® Technology platform is based on particles formed by the self-assembly of a small molecule," Leone-Bay explained, according to the news release. "Drugs can be loaded onto these particles, which are then dried to form a dry powder. Using a thumb-sized device, patients inhale a small amount of the powder, roughly equivalent to a pinch of salt.
"This powder dissolves immediately after inhalation and the drug is absorbed into the patient's bloodstream. Most importantly, the drug is absorbed ultra-rapidly so it becomes effective much more quickly than an injection of the same drug. For some drugs, ultra-rapid systemic delivery provides distinct clinical advantages over injection, including profiles that match the body's natural responses in processes like hormone secretion."
AFREZZA™ (insulin human rDNA origin) Inhalation Powder is an ultra-rapid acting insulin intended for use at mealtime to control the rapid rise in blood sugar levels that occurs in people with diabetes immediately after a meal
At other times, people with diabetes would take injections of other kinds of insulin. Leone-Bay said, according to the news release, that AFREZZA™ controls glucose as well as current state-of-the-art treatments, poses a lower risk of hypoglycemia than that typically associated with mealtime insulin therapy, and leads to less weight gain compared to other insulin treatments," according to Leone-Bay. "Additionally, and importantly, AFREZZA™ provides the unique benefit of a small, discreet, and easier-to-use inhalation device."