Afrezza (Insulin Human) Inhalation Powder

INTRODUCTION According to the National Diabetes Statistics Report, 29.1 million people have diabetes mellitus (DM) in the U.S., or approximately 9.3% of the population.1 DM imposes a fi nancial burden on both patients and the health care economy, with direct and indirect costs totaling $245 billion in 2012.1 All patients with type-1 DM (T1DM) require insulin therapy. Patients with type-2 DM (T2DM) may also become dependent on exogenous insulin as their disease progresses.2 Approximately 6 million people in the U.S. require insulin therapy.1 Insulin therapy allows for better glycemic control, but patients are often hesitant to make the transition to insulin because of its adverse-event profi le (e.g., hypoglycemia, weight gain) and because of fear of injections.3 Since injectable insulin was introduced into clinical practice in 1922, other routes of administration have been explored.4 Inhaled insulin, for example, offers the advantage of a larger area of absorption— approximately 70 to 140 square meters, or half of a tennis court.4 In 1924, the fi rst study of inhaled insulin was conducted in human subjects at doses 30 times higher than that of the subcutaneous (SC) route of administration.4,5 In 2006, the Food and Drug Administration (FDA) approved the fi rst inhaled insulin for patients with T1DM or T2DM. Exubera (Nektar Therapeutics/Pfi zer) was derived from recombinant human insulin (rDNA origin), with DrUG FOrECAST