Inhaled insulin approved

Afrezza, a rapid-acting, inhaled human insulin, was recently approved by the FDA to treat diabetes in adults.

It should be administered at the beginning of each meal. Safety and effectiveness were evaluated in more than 3,000 patients. In patients with type 1 diabetes, a comparison with insulin aspart showed that the inhaled insulin provided an HbA1c reduction that was slightly smaller but clinically noninferior. In patients with type 2 diabetes, combining the inhaled insulin with oral drugs provided a significantly greater reduction in HbA1c than oral drugs plus a placebo.

Afrezza is not a substitute for long-acting insulin, and for patients with type 1 diabetes, it must be used in combination with long-acting insulin. It is not recommended for the treatment of diabetic ketoacidosis or in patients who smoke. The drug carries a boxed warning and a Risk Evaluation and Mitigation Strategy due to instances of acute bronchospasm observed in patients with asthma and chronic obstructive pulmonary disease. It should not be used in patients with chronic lung disease. The most common adverse reactions in trials were hypoglycemia, cough, and throat pain or irritation, according to an FDA press release.