Diabetics Could See a Non-Injectable Form of Insulin by Spring

insulinMannKind Corp. has developed a product for Type 1 and Type 2 diabetes that could reinvent the way diabetics take their insulin eliminating the need for pump supplies, insulin pen needles, and other diabetic accessories. “AFREZZA® (pronounced uh-FREZZ-uh) is a novel, ultra rapid-acting mealtime insulin therapy in late stage clinical investigation for the treatment of adult patients with Type 1 and Type 2 diabetes mellitus for the control of hyperglycemia. It is a drug-device combination product, consisting of AFREZZA inhalation powder pre-metered into single use dose cartridges and the light, discreet and easy-to-use AFREZZA inhaler,” according to the product’s site at mannkindcorp.com. So there you have it, an inhaler has been invented for diabetics; and according to studies, is proven just as effective as the injectable form, MannKind hopes to obtain FDA approval by this spring, and many suspect that it will. This isn’t the first attempt at an inhaled form of insulin.

 

Pfizer Inc. was the first to market a diabetic insulin inhaler back in 2006, Exubera. The product failed to meet sales expectations and was withdrawn from the market, causing Pfizer almost $3 billion in pretax losses. It also caused competitors Lilly and Nova Nordisk to drop their similar products that were in advanced clinical trials, similar to where Afrezza is now. The cause of its failure is said to be because of the inconvenient nature of the product, such as its large and bulky size and the inability to provide the correct dosage. Afrezza, however, is likened to the size and shape of a whistle, easily concealable in the palm of one’s hand, and has tested well thus far.

 

Chairman and chief executive of MannKind, Alfred E. Mann, told Wall Street investors, “The clinical trial program has been extremely extensive and has already shown important, better benefits with Afrezza.”

 

“To date, the AFREZZA clinical program has involved 56 different studies of AFREZZA and over 5,300 adult patients. In clinical trials that compared AFREZZA to present “state of the art” insulin treatment, AFREZZA has shown: A significant reduction in post-meal glucose fluctuations, which are believed to be an important risk factor in the development of complications, the ability to achieve comparable levels of overall glucose control, lower fasting glucose levels, a lower risk of hypoglycemia, which is considered to be a major problem for patients (and) less weight gain than is typically associated with other insulin treatments,” according to the product’s website. The most common side effects reported during the trails were “hypoglycemia and mild, transient, non-productive cough.”

 

This isn’t to say that there won’t be a long road ahead for Afrezza. If and when the product is approved by the FDA, it is highly likely that they will face continued years of testing to determine the long-term effects of insulin on the lung, as well as effects of the inhaled powder for asthmatics and those with COPD in conjunction with their regularly inhaled steroids. There is also the challenge of generating revenue as it continues its research and development process, much of which has come from current 40 percent owner and billionaire, Mann. This worries some observers, and many would like to see MannKind partner with a large reputable pharmaceutical company to help with marketing, selling and delivery of the product. MannKind has said that they are actively considering partnerships.

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