Could You Add Inhalable Insulin to Your Routine?

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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!

29 Responses to Could You Add Inhalable Insulin to Your Routine?

  1. David says:

    This looks like a great new product for diabetics. It seems that if I had to decide between sticking myself with a needle and taking a puff from the inhaler that the choice would be very easy. When does the product get released to the market as I want to share the news with a diabetic friend who sadly has to stick herself before each meal and it is really a difficult thing to watch.

    • Cynthia Wright says:

      Just remember that the person will still have to inject their insulin dose, because the inhaled insulin is an additional dose. It is not stand alone therapy.

  2. Mdmd says:

    Not a bad article but it did lean more towards the negatives of AFrezza rather than the positives. Which is a shame because the positives greatly outweigh the negatives. Just take a look at the mnkd adcom video that has people who participated in the trial speeking, AFrezza completely changed some of ther lives. Also the “not a standalone option” bit is not entirely true. From what I’ve read it can be used as a standalone treatment for early t2s and pre-diabetics. Nice to see Afrezza getting some press though.

  3. Jamie says:

    I just got an insulin pump. It sounds like this would not be used in conjunction with a pump, correct?

    • Melissa says:

      I have a pump and have had it for 15 years. I love the ease of use, but it has its own drawbacks too. The insulin in my pump is rapid acting, but it takes longer to act than the same insulin given jn a single injection. I think this inhalable insulin could be used for those with pumps-you just wouldn’t bolus for a meal but use the inhalable insulin instead. The biggest pump upside for me is the basal insulin flexibility. The inhalable insulin wouldn’t change that, but sounds like it could control post meal blood glucose spikes better than my pump.

  4. Alpha says:

    Just an edit on the terms: The whole $925 has not yet been paid, only $150 to be followed with milestone payments.

    Otherwise, thank you for the article!

  5. Cliff Dean says:

    looks good and provides further options, woohoo!

  6. David says:

    i can see how this form of insulin delivery could improve my life, especially when traveling. My numbers suffer when I am out of my routine. Eating while traveling is always a problem and this inhaler system would allow me to maintain a more suitable insulin therapy while on the road. No more interruptions at restaurants while fumbling around in the restroom trying to inject privately. I will be discussing this inhaler system with my endocrinologist on my next visit.

  7. Ellen says:

    Sounds promising, but I have questions….How would this work for me? My mealtime insulin dose is 3 units. Could the devise be used to inhale just 3 of the 4 units in the inhaler? Is this a drug delivery system that medicare would approve and pay for?

    • Mary Collins says:

      The dosing is limited to what is offered in those little packets. I participated in a trial of this but with a different delivery device. Had to quit halfway through because of the lack of control. If you choke, snort or cough at all, you’re losing some or all of it, but you don’t know how much.
      It’s a nice idea, but…

  8. Tom McLaughlin says:

    Thanks for the article and including the negatives. Many articles are just taken from the press release and sadly are very unrealistic. I have been a diabetic for 49 years and have chosen to continue to inject my insulin. I find the limited dosage would prevent me from seriously considering this product. The fast acting nature and short active life of this product could prove useful, especially in bringing down an existing high BS. I personally do not find the injecting of insulin to be so bad….but I have lots of experience.

  9. Gail Bollard says:

    I use a pump. I am a type one for 45 years. I can see this as an aid for a high fat meal like pizza or fried food like french fries. I normally do not eat those things but it would be nice to do so every so often without the terrible blood sugar spike afterward. Aside from that I do not see a use for myself. I maintain a nearly 6.0 A1c on my pump. It took some time to achieve that but it works for me. Sorry I think I hit the post twice.

  10. Madeline says:

    Who decides to spend millions on a plastic inhaler rather than finding a cure??? And, it’s used WITH INSULIN!!!

    USELESS

  11. Jon says:

    There appears that there is no long term data on pulmonary function?

    • Mary Collins says:

      Participants in the trial -I took part using a different delivery device- go through regular, extensive testing on pulmonary function.
      Other than that though, it hasn’t been around long enough to know, I would think.
      Even with Excellant lungs, I would cough or choke using it from time to time. Then you lose an unknowable amt of the dose. Quit the trial halfway through because of lack of control using it.

  12. Nancy Lee says:

    I wear an insulin pump. The faster action of inhaled insulin could be an advantage in controlling blood sugar after meals. If it is covered by Medicare Part B, I would be interested in trying it to see how it works for me.

  13. Catherine Clark says:

    I was very excited to read this article. I have had Type I diabetes for 49 years and I have always struggled with morning blood glucose spikes. I will definitely be discussing the possibility of incorporating this new advance in my routine with my endocrinologist. To think I may be able to gain more control and take fewer injections is an awesome thought. I am hopeful.

    • WALTER WASYLKO says:

      Why hasn’t ORALYN insulin spray by Generex been approved in North America? It’s sprayed into mouth aimed towards cheeks & absorbed directly into mucous membrane using a RapidSpray applicator. Since it isn’t inhaled into lungs, there’s no effect on respiratory system.
      It was tested extensively in the 1990s & early 2000s & has been approved in South America & other countries.
      There’s a Glucose RapidSpray for instant glucose absorption for quick hypo treatment.
      I’m a well-controlled T1 for 48 years with A1c of 6.1 and still using Joslin’s physiologic multiple injection insulin program.

  14. Jim Easton says:

    I would be concerned about possible long term effects.

    How would people who are not insulin resistant control the dose. Increments of 4U seems rather coarse.

  15. Randy says:

    My understanding is that insulin must be injected or pumped into the endocrine system i.e sub-q. The inhaled insulin goes into the blood stream. What is it about this new product that makes it work in a manner that is contrary to the other insulins

  16. L.D. says:

    I would like to try Afrezza. My problem as of now is only a lack of 1st phase insulin release. My post prandial BG routinely goes over 200 unless I eat low carb. I’m tired, underweight, have neuropathy in my feet, reactive hypoglycemia and frequent infections, but because my A1c is good I’m finding it difficult to get treatment. I think Afrezza might be a stand alone option for patients like me… if there were endo’s willing to treat patients like me who are not typical T1 or T2.

  17. gail califano says:

    would like to learn more about it and if I could take it

  18. Sam Finta (AfrezzaUser) says:

    It is great to see my video posted in this article. I will make a post in more detail tomorrow responding to this article.

    I did want to say that I experienced non of the concerns that were raised in this article. If dosing would be an issue why is it that my glucose range was better than ever being on Afrezza? I only had 2 readings above 300 in 6 months and 0 readings below 69. As I mentioned at the Fda panel meeting for a period of 10 days I actually had my sugars locked in a very tight range never exceeding 125. I experienced no lows under this tight control. My a1c dipped into the 6s and I believe if I did not have to follow doctors orders a 5.9 would have been possible. I will respond more later.

    • Ed Varney says:

      Hi Sam, Glad to see you are posting your experiences from the trial you were on.. Its the folks like yourself who will help future users the most learning Afreeza benefits over old products.. I just wish there were more folks like yourself stepping up and talking out now.. This is the moment in time thats most critical to a great beginning for Afreeza.. Keep up your spirits and best of luck to you and your good health with Afreeza. I cant wait to get my mom on it now…

  19. Patty Ryan says:

    I love the idea of it be more fast acting than the apriva I am on now. I always spike after meals and the rapid response sound like it is just what I need.

    I am also on the Dexacom system to monator my blood sugars and love the system.

  20. p.n.krishnasamy says:

    it is good know abt the product.would like to know whether people had low sugar level during late night(ie)1 am to 2.30am)(50 to 25) can use tll it be lhis
    inhaler. will it be safe.kindly inform.

  21. Jay says:

    Nice and informative article. I wish one day we may able to get rid of injecting insulin.

  22. snort it,shoot it,use it,abuse it.remember,i did not have sex with that woman,
    sounds like the snortin bunny mr.fda is at it again. money money.
    forgetaboutit…
    stay with a shootin insulin 2x day. pen style. ez peezy—come on.

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