The U.S. Food and Drugs Administration has approved a new inhaled insulin named Afrezza for treating patients with diabetes.

The new treatment improves glycemic control in adults with diabetes mellitus. Afrezza need to be taken at the beginning of each meal, or within 20 minutes after starting a meal, the FDA reports.

"Afrezza is a new treatment option for patients with diabetes requiring mealtime insulin," said Jean-Marc Guettier, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research in a press release. "Today's approval broadens the options available for delivering mealtime insulin in the overall management of patients with diabetes who require it to control blood sugar levels."

To ensure the drug is safe for use, a clinical trial was conducted on 1,026 participants with type 1 diabetes and 1,991 patients with type 2 diabetes. Some of the patients were given Afrezza for treating their condition while the others were given mealtime insulin aspart (fast-acting insulin). The trial continued for 24 weeks. 

After 24 week, researchers found that the patients who were given Afrezza experienced a mean reduction in HbA1c (hemoglobin A1c or glycosylated hemoglobin, a measure of blood sugar control) that met the pre-specified non-inferiority margin of 0.4 percent. Afrezza provided less HbA1c reduction than insulin aspart.

The researchers caution that the drug is not a substitute for long-acting insulin and should be used in combination with long-acting insulin in patients with type 1 diabetes. It is also not recommended for the treatment of diabetic ketoacidosis, or in patients who smoke.

The drug comes with a boxed warning that patients with asthma and chronic obstructive pulmonary disease (COPD) may suffer from acute bronchospasm as a result of consuming Afrezza. The other side effects of the drug include hypoglycemia, cough, and throat pain or irritation.

Afrezza is manufactured by MannKind Corporation.