Given the concerns about earlier inhaled insulin
products, the potential impact of Afrezza on lung function has been investigated closely.
Heinemann et al., "Time-action profile of inhaled insulin
in comparison with subcutaneously injected insulin lispro and regular human insulin," Diabetes Care, vol.
"We believe our inhaled insulin
product is state-of-the-art and well-differentiated from powder based, non-electronic technology.
John Patton, who has over 25 years of experience developing inhaled insulin
and other inhaled therapies.
Prandial inhaled insulin
plus basal insulin glargine versus twice daily biaspart insulin for type 2 diabetes: a multicentre randomized trial.
Unfortunately, on June 27, 2014, the FDA approved another inhaled insulin
Non-invasive inhalational insulin is an attractive alternative to parenteral insulin.2 Clinical trials have shown that glucose-lowering activity of inhaled insulin
is comparable to subcutaneous insulin but with improved patient compliance.3 Its regular use is associated with fewer hypoglycaemic episodes and less risk for weight- gain as compared to subcutaneous insulin.4
Other companies have also tried to market inhaled insulin
but have ended their development programs.
At a meeting of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee, panelists voted 13-1 that the safety and efficacy data for the inhaled insulin
, delivered with an inhaler, supported approval for treatment of adults with type 1 diabetes; they voted 14-0 that the data supported approval for treatment of adults with type 2 diabetes.
Pittas, "Meta-analysis: efficacy and safety of inhaled insulin
therapy in adults with diabetes mellitus," Annals of Internal Medicine, vol.
The clinical effectiveness and cost-effectiveness of inhaled insulin
in diabetes mellitus: a systematic review and economic evaluation.
The company said it was informed that the agency would not make a decision on whether to approve the product, a whistle-sized inhaled insulin
device, by its Dec.