On January 27, 2006, the FDA approved the inhaled insulin Exubera® for use in adults with type 1 and type 2 diabetes. This follows the September 2005 FDA advisory panel recommendedation for approval.
Inhaled insulin acts much like injected rapid acting insulin analogs (NovoLog, Humalog, Apidra) and is used to cover mealtime carbohydrates. People with type 1 diabetes who use inhaled insulin must still take injections of a long acting basal insulin, such as Lantus or Detemir.
Study after study has shown that inhaled insulin works well and that study participants, with both type 1 and type 2 diabetes, like inhaled insulin. While the long term effects of inhaled insulin are not known, studies to date indicate that there is little if any impact on lung function for healthy people.
Some people, particularly parents of young kids with type 1 diabetes, are quite concerned about the potential for lung damage from decades of use. We won't be able to answer these concerns until inhaled insulin has been in use for many years. In the meantime, if inhaled insulin helps people type 2 diabetes get on insulin therapy sooner than they would otherwise, it has the potential to help more people achieve better control, and that is good for all of us.
- FDA Approves First Ever Inhaled Insulin Combination Product for Treatment of Diabetes
- Summary Minutes of the Endocrinologic and Metabolic Drugs Advisory Committee meeting for September 8, 2005.
- Advisory Committee Briefing Document - EXUBERA (240 page PDF).
- Endocrinologic and Metabolic Drugs Advisory Committee of September 8, 2005 - Food and Drug Administration Briefing Information.
- Exubera Slides.
- Inhaled insulin for diabetes mellitus. Free full text available in HTML and PDF formats.
Selected Studies About Inhaled Insulin
- EXUBERA®: Pharmaceutical Development of a Novel Product for Pulmonary Delivery of Insulin. Free full text available in PDF format.
- Dose Response of Inhaled Dry-Powder Insulin and Dose Equivalence to Subcutaneous Insulin Lispro.
- Use of inhaled insulin in a basal/bolus insulin regimen in type 1 diabetic subjects: a 6-month, randomized, comparative trial.
- The Effect of Insulin Antibodies on the Metabolic Action of Inhaled and Subcutaneous Insulin: A prospective randomized pharmacodynamic study.
- Time-action profile of inhaled insulin in comparison with subcutaneously injected insulin lispro and regular human insulin. Free full text available in HTML format.
- Antibody response to inhaled insulin in patients with type 1 or type 2 diabetes. An analysis of initial phase II and III inhaled insulin (Exubera) trials and a two-year extension trial.
- Availability of Inhaled Insulin Promotes Greater Perceived Acceptance of Insulin Therapy in Patients With Type 2 Diabetes. Also available in PDF format.
- Efficacy and safety of inhaled insulin (Exubera) compared with subcutaneous insulin therapy in patients with type 1 diabetes: results of a 6-month, randomized, comparative trial. Free full text available in HTML and PDF formats.
- Patient satisfaction and glycemic control after 1 year with inhaled insulin (Exubera) in patients with type 1 or type 2 diabetes. Free full text available in HTML and PDF formats.
- Inhaled insulin for diabetes mellitus.
- Inhaled insulin: Exubera.
- Facts About Exubera by Pfizer explains the newly approved inhaled insulin and has a photograph of the inhaler, collapsed and expanded.
- FDA Approvals: Exubera and Vaprisol offers CME credit.
- Focus On: Exubera An Orally inhaled insulin.
- Pfizer Receives FDA Approval for Exubera, the First Inhalable Form of Insulin for Controlling Type 1 and Type 2 Diabetes in Adults
- FDA Advisory Committee Recommends Approval Of Exubera® For Use In Adults With Type 1 And Type 2 Diabetes (sanofi-aventis)
- FDA Advisory Committee Recommends Approval of Exubera® for Use in Adults with Type 1 and 2 Diabetes (Pfizer)
- Data Presented At American Diabetes Association Scientific Sessions Support Exubera® Efficacy And Safety Profile In Type 1 And Type 2 Diabetes
- Exubera from Nektar
- Nektar's Pulminary Delivery System includes a sketch of the inhaler device
- Diabetes: inhaled insulin yet to convince all.
The Exubera inhaler, collapsed (left) and expanded (right), with blister packs of insulin in front.
When closed, the inhaler is about the size of an eyeglass case. The inhaler weighs four ounces (about 114 grams).
Exubera logo and images from Facts About Exubera by Pfizer.
February 5, 2006
Last Updated: Mon Feb 20 21:03:59 2006
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