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Is Inhaled Insulin Delivery Still A Possibility? Why Has It Been A Commercial Failure?

September 24, 2009

The commercial failure of Exubera® (Pfizer, New York, NY), the first inhaled insulin product to come to market, led other companies like as Eli Lilly-Alkermes to halt studies of similar drug delivery in development intended to contend for a share of the lucrative diabetes market. Does this signal defeat for efforts to discharge insulin via the lungs? The science and pecuniary standing behind the Lilly-Alkermes decision to break off trials of the AIR® inhaled insulin product are explored in a special supplement to Diabetes Technology & Therapeutics, a peer-reviewed diary published by Mary Ann Liebert, Inc. The continuation is available eager online athttp:// www.liebertpub.com/dia

The supplement presents the data on AIR inhaled insulin that has been made profitable by Eli Lilly (Indianapolis, IN) and Alkermes (Cambridge, MA), co-developers of the drug. Eight articles describe various protocols in which the effectiveness and safety of AIR were compared to traditional insulin injections in patients with type 1 or type 2 diabetes. These studies represent noninferiority trials, in that AIR was evaluated for its possible to be at minutest for the reason that safe and effective considered in the state of subcutaneous (SC) insulin across a range of parameters.

Satish K. Garg, MD, Professor of Medicine and Pediatrics at the University of Colorado Denver, and Editor-in-Chief of Diabetes Technology & Therapeutics, and colleagues report the results of a 2-year Phase 3 trial conducted in 385 patients, in each article entitled, “Two-Year Efficacy and Safety of AIR Inhaled Insulin in Patients by Type 1 Diabetes: An Open-Label Randomized Controlled Trial.” The study found AIR to be inferior to SC insulin (in a noninferiority clinical criterion design) in its ability to maintain optimal blood glucose levels over time, based on measurements of glycosylated hemoglobin (HbA1c).

Similarly, Angel L. Comulada, MD, FACE, Instituto de Endocrinología, Diabetes & Metabolismo, Toa Baja, Puerto Rico, and coworkers demonstrated inferiority of AIR in their study of 500 patients through type 1 diabetes over 6 months. They fame their findings in the article “Efficacy and Safety of AIR Inhaled Insulin Compared to Insulin Lispro in Patients by Type 1 Diabetes Mellitus in a 6-Month, Randomized, Noninferiority Trial.”

“The question now leavings whether this route of delivering insulin has been exhausted or if it at rest remainder to be explored,” produce Satish Garg, MD and William Kelly, BS from the University of Colorado Denver in the Editorial “Insulin Delivery via Lungs - Is It Still Possible?” MannKind Corporation recently filed a New Drug Application by the FDA for Technosphere® Insulin. It offers faster storm of agency with lower postprandial blood glucose excursions especially in the first two hours and is moment neutral, according to the Editorial.

Source:
Julia Chapman
Mary Ann Liebert, Inc./Genetic Engineering News

Written by Samanta · Filed Under Pharmacy Industry News