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There's still no such thing as an insulin pill. But the FDA recently approved Afrezza, a fast-acting insulin that does not have to be taken by injection, for use before meals.

The only medication for diabetes that always works, if it is taken at the right time and in the right dosage, is insulin. Other medications for diabetes stimulate the pancreas to release more insulin, or make cells more sensitive to insulin, or slow down the process of digestion so that the body does not need as much insulin as quickly as it would otherwise. Insulin itself, however, is still needed to keep sugar (and fat) moving from the bloodstream into cells.

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The problem with insulin has always been that is has to be injected.

"Pills for diabetes" are not actually insulin. And aside from the fact that some diabetics just don't like getting shots, there are potential complications of insulin injections such as hitting a vein and delivering the insulin to the body too fast, or broken needles, or not filling the syringe properly and injecting a (usually harmless) air bubble. All of the issues with insulin injection may soon become moot with the introduction of a new inhaled insulin called Afrezza, developed by MannKind Corporation.

An Inventor's Passion

MannKind, based in Valencia, Calif., is run by Alfred E. Mann, a highly successful aerospace and medical device entrepreneur still very active at age 88. MiniMed, a company he started that made insulin pumps for diabetics, was sold to Medtronic for about $3 billion in 2001. Mr. Mann also started companies that developed pacemakers and cochlear implants.

Developing inhaled insulin, however, has been his passion. 

“Diabetes is a major health problem in the United States,” Mann said after an FDA advisory panel gave preliminary approval to Afrezza in April 2014, “and we are committed to bring Afrezza to the many patients who might benefit from this novel product.”

Mann's commitment took the form of spending about $2.3 billion of his personal fortune on research and development of the product.

How Well Does Afrezza Work?

The studies submitted to the FDA review panel were summarized as:

"Efficacy and safety data came from studies involving a total of 3017 patients, including 1026 with type 1 and 1991 with type 2 diabetes. At 24 weeks, Afrezza reduced HbA1c levels by the prespecified end point of 0.4 percentage points in both groups. Hemoglobin A1c reduction was inferior to that of insulin aspart among type 1 patients but significantly superior to placebo among type 2 patients who were also taking oral glucose-lowering medications."

What does that mean in plain English?

Afrezza was tested on an unusually large number of volunteers, twice the number needed for making sure the results weren't a statistical fluke. It is not a cure-all for diabetes.

The benefits for using Afrezza are comparable to "adding a pill" for type 2 diabetics. It's not as good as injected Novolog for type 1 diabetics, but it's "better than nothing" for type 2 diabetics. 

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