Navigation Links
Is inhaled insulin delivery still a possibility? Why has it been a commercial failure?
Date:9/23/2009

New Rochelle, NY, September 23, 2009The commercial failure of Exubera (Pfizer, New York, NY), the first inhaled insulin product to come to market, led other companies such as Eli Lilly-Alkermes to halt studies of similar drug delivery in development intended to compete for a share of the lucrative diabetes market. Does this signal defeat for efforts to deliver insulin via the lungs? The science and circumstances behind the Lilly-Alkermes decision to discontinue trials of the AIR inhaled insulin product are explored in a special supplement to Diabetes Technology & Therapeutics, a peer-reviewed journal published by Mary Ann Liebert, Inc. (www.liebertpub.com). The supplement is available free online at www.liebertpub.com/dia

The supplement presents the data on AIR inhaled insulin that has been made available 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 which AIR was evaluated for its potential to be at least as safe and effective as 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 an article entitled, "Two-Year Efficacy and Safety of AIR Inhaled Insulin in Patients with Type 1 Diabetes: An Open-Label Randomized Controlled Trial." The study found AIR to be inferior to SC insulin (in a noninferiority clinical trial 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 Endocrinologa, Diabetes & Metabolismo, Toa Baja, Puerto Rico, and coworkers demonstrated inferiority of AIR in their study of 500 patients with type 1 diabetes over 6 months. They report their findings in the article "Efficacy and Safety of AIR Inhaled Insulin Compared to Insulin Lispro in Patients with Type 1 Diabetes Mellitus in a 6-Month, Randomized, Noninferiority Trial."

"The question now remains whether this route of delivering insulin has been exhausted or if it still remains to be explored," write Satish Garg, MD and William Kelly, BS from the University of Colorado Denver in the Editorial "Insulin Delivery via LungsIs It Still Possible?" MannKind Corporation recently filed a New Drug Application with the FDA for Technosphere Insulin. It offers faster onset of action with lower postprandial blood glucose excursions especially in the first two hours and is weight neutral, according to the Editorial.


'/>"/>

Contact: Julia Chapman
jchapman@liebertpub.com
914-740-2147
Mary Ann Liebert, Inc./Genetic Engineering News
Source:Eurekalert

Related medicine news :

1. Study Demonstrates That QVAR(R) is More Cost-Effective Than Other Inhaled Corticosteroid (ICS) Asthma Therapy Options
2. Comparative Effectiveness Research Study in Mayo Clinic Proceedings Demonstrated Asthma Patients Had Better Overall Results with Oral Controllers than Inhaled Products
3. Jefferson Headache Center study shows novel, orally inhaled migraine therapy effective
4. PARI Pharma Receives 2nd ODD From EMEA; Moves Inhaled Tobramycin - eFlow Technology Program Forward
5. Cleanose Personal Air Filters Offer Added Protection From Inhaled Viruses/ Swine Flu/ H1N1 and Other Inhaled Dangers
6. U.S. Food and Drug Administration Extends Action Date for Inhaled Treprostinil (Tyvaso) New Drug Application by Three Months
7. Inhaled Corticosteroids Boost Pneumonia Risk in COPD
8. UNC, Harvard develop inhaled TB vaccine
9. Inhaled tuberculosis vaccine more effective than traditional shot
10. Researchers Make Insulin-Producing Cells From Adult Skin Cells
11. JNCI news brief: High serum insulin levels and risk of prostate cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/16/2017)... New York (PRWEB) , ... January 16, 2017 ... ... SightMD today announced the addition of Victor Giamos, MD to their ... of SightMD and Managing Partner at North Shore Eye Care, a division of ...
(Date:1/16/2017)... , ... January 16, 2017 , ... ... availability of the newly updated International Audit Protocol Consortium (IAPC) EHS audit protocol ... protocols to understand the scope of their EHS regulatory obligations and rapidly collect, ...
(Date:1/16/2017)... ... ... St. Louisans are well-aware of the following facts at present:, ... be having no effect on keeping this particularly bad strain of the flu away , ... sneezing, or sniffling , These facts are well-known among the team at ...
(Date:1/16/2017)... Beverly Hills, CA (PRWEB) , ... January 16, ... ... published a manuscript in the Aesthetic Surgery Journal , the official journal ... study he conducted on lower eyelid retraction surgery. The procedure is designed to ...
(Date:1/16/2017)... ... January 16, 2017 , ... One thing common to all types ... to test for, as well. The money spent screening for and treating cancer in ... U.S. screen patients for cancer more than in any other country that has an ...
Breaking Medicine News(10 mins):
(Date:1/13/2017)... , January 13, 2017 This ... see how they have fared at yesterday,s closing bell: ... Biopharma Inc. (NASDAQ: GALE ), and ACADIA ... harness cellular and biomolecular processes to develop technologies and ... environmental footprint, feed the hungry, use less and cleaner ...
(Date:1/13/2017)... 2017 The 2016 election resulted in ... states voting in favor of legalizing cannabis for recreational use, ... in the U.S. In addition, the state of ... cannabis products sales. The ArcView Group has published an updated ... cannabis sales in the U.S. last year reached $6.7 billion, a ...
(Date:1/13/2017)... 2017   JDRF , the leading global ... pleased to announce that after more than a ... & Medicaid Services (CMS) has recognized continuous glucose ... use in making diabetes treatment decisions as durable ... eligible for coverage under Medicare. JDRF has been ...
Breaking Medicine Technology: