title: A second-generation inhaled insulin for diabetes mellitus.
abstract: OBJECTIVE
  The pharmacologic properties of a recently approved inhaled insulin product, its unique delivery system, and the results of clinical safety and efficacy trials are reviewed.
  
  
  CONCLUSIONS
  Afrezza (also called Technosphere Insulin, MannKind Corporation, Valencia, CA) is a novel ultrarapid-acting insulin formulation indicated for use in improving glycemic control in selected patients with type 1 or type 2 diabetes mellitus. Afrezza is not intended as a substitute for traditional basal therapy with injectable long-acting insulin but may be used to provide prandial insulin coverage; it must be used in combination with long-acting insulin in patients with type 1 diabetes. Administered before meals using a dry-powder inhalation device, Afrezza is formulated with a novel excipient (fumaryl diketopiperazine) that dissolves instantly in lung fluid and releases recombinant human insulin for absorption. In clinical trials, rates of hypoglycemia in Afrezza-treated patients were significantly lower than rates reported in comparator groups receiving injectable insulin products. The most commonly reported adverse effect of Afrezza is coughing, which tends to occur shortly after inhalation and is typically mild. Afrezza is not recommended for use in patients who smoke (or have recently stopped smoking) and those with a chronic lung disease such as asthma or chronic obstructive pulmonary disease. Afrezza is not recommended for the treatment of diabetic ketoacidosis.
  
  
  CONCLUSIONS
  Afrezza is a safe and effective treatment for selected adults with type 1 or type 2 diabetes, potentially providing an alternative to injectable insulin for prandial blood glucose control.
authors.affiliation: Grace Ledet, M.S., is Research Associate; Richard A. Graves, M.S., is Senior Research Associate; and Levon A. Bostanian, Ph.D., is Professor of Pharmaceutics, Division of Basic Pharmaceutical Sciences, College of Pharmacy, Xavier University of Louisiana, New Orleans. Tarun K. Mandal, Ph.D., is Professor and Director, Center for Nanomedicine and Drug Delivery, Division of Basic Pharmaceutical Sciences, College of Pharmacy, Xavier University of Louisiana.
authors.forename: Grace
authors.initials: G
authors.lastname: Ledet
authors.affiliation: Grace Ledet, M.S., is Research Associate; Richard A. Graves, M.S., is Senior Research Associate; and Levon A. Bostanian, Ph.D., is Professor of Pharmaceutics, Division of Basic Pharmaceutical Sciences, College of Pharmacy, Xavier University of Louisiana, New Orleans. Tarun K. Mandal, Ph.D., is Professor and Director, Center for Nanomedicine and Drug Delivery, Division of Basic Pharmaceutical Sciences, College of Pharmacy, Xavier University of Louisiana.
authors.forename: Richard A
authors.initials: RA
authors.lastname: Graves
authors.affiliation: Grace Ledet, M.S., is Research Associate; Richard A. Graves, M.S., is Senior Research Associate; and Levon A. Bostanian, Ph.D., is Professor of Pharmaceutics, Division of Basic Pharmaceutical Sciences, College of Pharmacy, Xavier University of Louisiana, New Orleans. Tarun K. Mandal, Ph.D., is Professor and Director, Center for Nanomedicine and Drug Delivery, Division of Basic Pharmaceutical Sciences, College of Pharmacy, Xavier University of Louisiana.
authors.forename: Levon A
authors.initials: LA
authors.lastname: Bostanian
authors.affiliation: Grace Ledet, M.S., is Research Associate; Richard A. Graves, M.S., is Senior Research Associate; and Levon A. Bostanian, Ph.D., is Professor of Pharmaceutics, Division of Basic Pharmaceutical Sciences, College of Pharmacy, Xavier University of Louisiana, New Orleans. Tarun K. Mandal, Ph.D., is Professor and Director, Center for Nanomedicine and Drug Delivery, Division of Basic Pharmaceutical Sciences, College of Pharmacy, Xavier University of Louisiana. tmandal@xula.edu.
authors.forename: Tarun K
authors.initials: TK
authors.lastname: Mandal
mesh_terms: D000280:Administration, Inhalation; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D002986:Clinical Trials as Topic / Q000379:methods; D003920:Diabetes Mellitus / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007328:Insulin / Q000008:administration & dosage*
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin