By: Sang Hyo Kim, Staff Editor
Near the end of December, the pharmaceutical company, MannKind Corp, will submit their clinical data to the U.S Food and Drug Administration for the approval of an inhaled dosage form of insulin, Afrezza®.1 Administered with the Dreamboat inhaler, this inhaled dosage form delivers insulin packaged into single dose cartridges.1 The Dreamboat inhaler can be used for a range of products and therapies, and can serve as hope to the millions of diabetics throughout the world.2 With an estimated number of half a billion diabetics by 2030, the approval of Affrezza® can improve quality of life and create a multi-billion dollar market for Mannkind.2
Mannkind states that their new dosage form is more effective than other insulin products on the market and that its cost will be comparable to current injectable pens.3 Most importantly however, the Dreamboat inhaler is pocket-sized and will be convenient for diabetics to use anywhere, compared to injecting insulin. The insulin is provided as a small tablet and is placed into the chamber of the inhaler where it is then crushed into a fine powder when the chamber is closed.4 Insulin therapy is maximized when it is administered in a way that mimics the body’s normal pattern of insulin release. Insulin levels normally spike in response to the ingestion of food. Because Afrezza® takes twelve to fourteen minutes to reach peak blood levels, the time of administration would be immediately preceding a meal.3 Mannkind believes that this inhaled dosage form will revolutionize insulin therapy for diabetes because of its characteristic fast action, which is superior to any existing, rapid onset injectable insulin product.4
The idea of inhaled insulin is not new. It was attempted in the past but did not prove to be successful. In 2007, Pfizer Inc. withdrew its inhaled insulin product, Exubera®, from the market because it was too costly to produce in the face of poor sales.2 Additionally, Exubera® was large in size, decreasing its appeal. The FDA also rejected Afrezza® in 2011 for lack of sufficient data on its efficacy.2 Mannkind was told to conduct two trials again and therefore performed Study 171 and Study 175, referred to as the AFFINITY trials.5
Study 171 compared various endpoints of glucose control in three different groups: 518 patients with type I diabetes receiving either insulin aspart injections (NovoLog®), Afrezza® delivered via the Dreamboat inhaler, or Afrezza® delivered via an older device, the MedTone inhaler. The study was performed over 24 weeks, during which HbA1c levels, fasting blood glucose levels, and incidence of hypoglycemia were all favorable in patients receiving Afrezza® via the Dreamboat inhaler compared to the other two groups.5,6 Study 175 was performed on 353 patients with uncontrolled type II diabetes, currently on metformin with or without another oral medication. These patients were randomized to receive either Afrezza® or Technosphere, an older inhaled insulin on the market, both delivered by the Dreamboat inhaler. This study revealed that HbA1c levels were significantly lower in patients receiving Afrezza®, with a larger proportion of patients reaching target levels below 7% and 6.5%.2,5 Results from both trials indeed showed the benefits of Afrezza® over previous inhaled, injected, and oral diabetes medications.5
According to the Transparency Market Research, the global insulin market is expected to reach $32 billion in 2018.1 Furthermore, the Centers for Disease Control and Prevention estimates that the number of Americans with diagnosed diabetes has more than tripled (5.6 million to 20.9 million) from 1980 to 2011.1 Because diabetics typically start out with orally-administered medication and often move on to injectable products to regulate blood-sugar levels, the approval of an inhaled insulin will surely be convenient, increasing patient compliance.2 Healthcare providers and patients are both excited to see whether Afrezza® will be approved.
- Scutti, S. Afrezza, new inhaled insulin product, breezes through phase III trials: will diabetics soon be free of needles? http://www.medicaldaily.com/afrezza-new-inhaled-insu. Published August 15th, 2013. Accessed November 6th, 2013.
- Dey, E. UPDATE 2-MannKind’s inhaled insulin offers diabetics freedom from shots. Reuters. http://www.reuters.com/article/2013/08/14/mannkind-study-idUSL4N0GF29E20130814. Published August 14th, 2013. Accessed October 31st, 2013
- Bachman, J. For diabetics, a new insulin inhaler could replace shots as early as 2014. BloombergBusiness Week. http://www.businessweek.com/articles/2013-08-14/for-diabetics-a-new-insulin-inhaler-could-replace-shots-as-early-as-2014. Published August 14th, 2013. Accessed November 1st, 2013
- Leach, Chris. Inhalable insulin-a breathtaking development. Insulin Nation. http://insulinnation.com/inhalable-insulin-a-breathtaking-development/. Published March 28th, 2013. Accessed November 1st, 2013
- Fiore K. Data promising for next-gen inhaled insulin. Medpage. http://www.medpagetoday.com/Endocrinology/Diabetes/40988. Published August 14th, 2013. Accessed September 22nd, 2013.
- Snapinn, S. Noninferiority trials. PMC:US National Library of Medicine National Institutes of Health. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC59590/. Published online 2000 July 31. Accessed November 6th, 2013