Joslin does not endorse specific products or companies. This post is meant to be informational only.
Injecting insulin in the break room, at a restaurant, or at a dinner party can be difficult. Some people are embarrassed by having to dose in public. Others experience a blood sugar spike while they’re waiting for their insulin to kick in. Now, there may be a new way. This June, the FDA approved an inhalable insulin known as Afrezza.
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Afrezza is an ultra-rapid-acting powder designed to be taken before a meal. It is designed for adults with type 1 or type 2 diabetes, but it is not yet approved for kids. It’s important to understand that Afrezza is not a stand-alone drug. This novel delivery system was created to control post-meal blood sugar spikes, and should be used with existing insulin treatments. This means you can’t just stop your injections altogether. The new drug is simply another tool in your self-care arsenal.
The powdered insulin is administered via a whistle-sized inhaler called the “Dreamboat”. The powder dissolves immediately when inhaled, and the insulin is quickly absorbed into the bloodstream. The new insulin hits peak activation within 12 to 15 minutes and leaves the system relatively quickly. Comparatively, some short-term insulin treatments take at least 20 minutes to start working, peak at 2-3 hours, and can stay in the system for as long as five hours.
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Unlike traditional insulin, this new powdered insulin needs no refrigeration and can be stored at room temperature. The plastic inhaler is meant to be thrown away after 15 days to prevent any powdery buildup that could clog the device. Each single-use cartridge holds either 4 or 8 units, with the possibility of a 12-unit cartridge available in the future.
Robert Gabbay, M.D., Ph.D., Chief Medical Officer and Senior Vice President of the Joslin Diabetes Center, thinks Afrezza could be a useful new tool, but he cautions that it’s not without its drawbacks. “One of the challenges with these treatments is that it does not allow patients to fine tune their insulin doses,” he says. “It could be difficult to use for those that require higher dosing because of the need for multiple inhalations.”
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Patients thinking about taking this new form of insulin should understand all the risks. Afrezza is not recommended for patients who smoke, have asthma or chronic lung disease. If you’re at high risk for Diabetic Ketoacidosis, (DKA) you probably shouldn’t start this new inhalable insulin at all. During the clinical trials, there was an increased rate of DKA.
There was also evidence that the new delivery system interfered badly with Thiazolidinediones (TZD’s). A small subset of patients in the clinical trials taking TZD’s experienced fluid retention around their heart; a serious problem which could lead to heart failure.
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If patients start taking inhalable insulin, they should diligently monitor their blood glucose levels. You never know exactly how your body is going to react to pharmaceuticals and it’s critical that if something goes wrong you can get the necessary medical attention you need.
“Even though this is FDA approved,” says Dr. Gabbay, “the concerns about safety for this new form of drug are still out there.”
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The California biotech company MannKind Corp. has already put Afreza through two FDA submissions. At first, regulators turned down Afrezza. They asked for more clinical data to appease concerns about safety and effectiveness. Part of the problem was the new Dreamboat inhaler design, which was introduced after the initial FDA screening. After resubmitting Afrezza in October 2013, the FDA finally decided this new inhalable insulin is safe and effective for adult use.
Over a decade ago, Pfizer introduced another inhaled insulin product called Exubera but ultimately discontinued the drug after low market sales.
In August of this year, the French biotech company Sanofi will pay a total of $925 million for the right to market Afrezza. According to Sanofi, they plan to start distributing Afrezza in early 2015.
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If you’re interested to see what the Afrezza inhaler looks like, a patient from one of the clinical trials posted a short video of himself using the Dreamboat design.
“To date, the drug appears safe but continued vigilance will be important,” says Dr. Gabbay. “However, Afrezza is a potentially valuable new tool for the treatment of diabetes, particularly those reluctant to use insulin injections.”
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What do you think about inhalable insulin? Would it augment your injectable insulin doses during mealtime? Are you excited about this new delivery system or do you think it will be just another flash in the pan? Let us know what you think in the comments!