Diabetes Self-Management Blog

It was proclaimed “one of the most expensive failures in pharma history,” achieving a tiny fraction of its expected sales and ultimately costing Pfizer $2.8 billion in losses. Exubera, the first inhalable insulin to reach the market, was discontinued in 2007, less than two years after its debut. It was plagued by a bulky inhaler device, confusing units of powder measurement, and concerns about its long-term safety and effect on lung function. But after this colossal flop, a new company is intent on giving inhaled insulin another chance.

A recent article from HealthDay profiles Afrezza, an inhalable insulin manufactured by MannKind Corp. that is awaiting approval for marketing by the US Food and Drug Administration (FDA). Afrezza, according to an executive at MannKind, is absorbed into the blood from the lungs through a new chemical mechanism, different from how Exubera was absorbed. As a result, it works very quickly, peaking in action 12–15 minutes after inhalation, compared with Exubera’s 45–60 minutes. This fast action could let users calibrate their insulin doses more closely to their meals, enabling quick adjustments if blood glucose remains high after the first mealtime insulin dose. It could also lessen the risk of hypoglycemia, since the insulin would not continue to lower blood glucose for very long after a meal.

But concerns about inhaled insulin remain, including those stemming from a higher rate of lung cancer linked to Exubera after its phasing-out had begun. In response, MannKind touts a study of Afrezza in rats that showed no increase in lung cancer risk — but as with any new drug, the long-term risks in humans remain unknown.

What do you think — if you take insulin, would you be interested in switching to an inhaled delivery system? Would you be willing to pay more for inhaled insulin? Does avoiding injections strike you as an attractive feature of inhaled insulin, or does the burden of injections tend to be exaggerated? Do you think a faster-acting mealtime insulin would be helpful? Leave a comment below!

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Comments
  1. Despite the risks associated with the new drug (risk of lung cancer specifically) I would definitely try this new drug. I have been a Type 1 now for 22 years and am always seeking new and better ways to treat this disease. If there is a way that I can live a better and more free life, I am all for it. In today’s world, who is to say that I won’t get lung cancer from simply living in a big city let alone from a medication that could allow me to live a fuller, richer life? Any diabetic knows what it’s like to feel your blood glucose be high and you have to sit through the agony until the insulin finally kicks on some 60-90 minutes later. Fifteen minutes would be a welcomed relief.

    Posted by Mandy |
  2. if you take insulin, would you be interested in switching to an inhaled delivery system? NO
    Would you be willing to pay more for inhaled insulin? NO
    Do you think a faster-acting mealtime insulin would be helpful? Yes.
    Inhaled insulin is only useful for type 2’s who still produce a fair amount of insulin and just need a bit of help. Otherwise, getting the right dose would be next to impossible.

    -Lloyd

    Posted by Lloyd |
  3. The answer pure and simple..absolutely. My daughter is diabetic 1 and as important as a small inhaler would be to her instead of injections it pales in comparison to the fast acting benefit. Balancing the number with what is for her about 75 minutes of lag time is extremely difficult. Fully aware it would not be available immediately at her age of 13, we pray for insulin that has the same reaction time as a healthy pancreas. The real unanswerable question is what wouldn’t I pay for this benefit?

    Posted by Gary Jones |
  4. I would love to have it to use after taking shots for more than 60 years. Afreeza is administered from a small device about the size of your little finger, gets rapidly absorbed, and is easy to dose and use. Afreeza also gets about 4 times better absorption than the horribly designed Exubera product. It will be a great option for both type 1 and type 2 patients. Also, check out the real story on Exubera and causing cancer, that simply was not true. Since there is no information about the cost of it, it is unreasonable to say it will cost significantly more.

    Posted by Keith |
  5. Being an insulin dependant juvenile diabetic for 30 years now I wouldn’t think twice about using it! Just the thought of not being a pin cushion is inviting…..

    Posted by Amy |
  6. I would say definitely yes. I was on the trials for exhubera for nine months and had excellent results. It is very easy to use. I had a very high A1c whwn I started and my numbers went down dramatically to about a 6. When I went off of the exhubera my numbers skyrocketed. I did not have any adverse effects. The Inhaler itself is a bit large and hopefully Mannkinds version will be much smaller. The only thing about exhubera is that I did put on weight, so you must have some kind of diet and exercise program in place. I look forward to see Mannkinds new medicine hit the market. I thin k the biggest problem Pfizer had was its marketing. The doctors did not know how to use it as well as the Pharmacists. Pfizer did a terrible job of marketing and making the public comfortable with that product.
    I am now unfortunately on regular insulin.

    Posted by David |
  7. Type 2 diabetic. I would be interested in finding out more about this medication. An inhalant that is faster acting sounds like a great answer. I am on an insulin pump and do have some ups and downs. My concern would be long-term effects and what would the cost be.

    Posted by Rue Judd |
  8. I did a search on this new drug and found that the FDA has already turned it down. So much for new therapies.

    Posted by Neil Johnson |
  9. Hi Mr. Johnson,

    Thanks for your comment. To clarify, the FDA has not turned down Afrezza, but rather has asked for additional information with which to evaluate the product. According to an article on Reuters.com,

    The agency asked for additional information about data designed to support the clinical utility of the device, known as Afrezza, and information about how comparable the commercial version of the product is to the version used in clinical trials… The FDA did not request an additional clinical trial, nor did it cite any safety concerns. But it did ask for updated safety data. The agency also requested changes to the proposed labeling of the cartridges, foil pouches and cartons used in the device.

    For more information, see the full article here.

    Thank you for your interest in Diabetes Self-Management.

    Sincerely,
    Diane Fennell
    Web Editor

    Posted by Diane Fennell |
  10. Idefinitely would use the inhaled ibsulin. I did very well on EXubera for two ywars, without any lung problems.

    Posted by Eleanor Birch |
  11. No, I would not be interested in an inhaled insulin. I an skeptical its accuracy. I am type 2 and have very little insulin production left in my pancreas. I been on an insulin pump since 2006. If I had to give up my insulin pump, I would prefer to return to multiple daily insulin injections (MDI) with a syrenge than use inhaled insulin. It was the better control of the insulin delivered and not the reduction of pain that made me move from manual insulin injection.

    Leslie

    Posted by Leslie L Gross |
  12. I am willing anything without a needle. PLEASE CONTACT ME WITH OPTIONS.

    Posted by terry starcher |
  13. My wife has type 1. She was on exubera for one year. It gave her the feeling of being cured.
    It failed becuse it was poorly marketed, and for no other reason.
    Pzier had many excuses for their failures. But they failed probably because they had the wrong people working in sales.

    She is hoping the fda gets going on Mannkind’s device. Please keep us all informed

    Posted by Herb Hammer |
  14. I would really be interested in the new inhaled insulin.

    Posted by Madhav |
  15. This inhaleable insulin sounds promising but I have been using an insulin pump for 16 years and the management of my type 1 diabetes is wonderful. I am living with diabetes for 56 years and the pump is calculated to my personal insulin needs. It using regular insulin which begins working within 15 minutes of giving a “bolus” to accommodate my carb intake. The pump gives a slow steady infusion of insulin and gives me freedom to eat and do activities when I want. There are no daily multiple shots. The infusion site is changed every 2 days. have any of the people who commented here know about the pump? They should look into and when the inhaleable is available change to that.

    Posted by Susan |
  16. it would be a big welcome especially if it does not require special storage conditions and have minimal side effects

    Posted by kariuki |
  17. My son was recently diagnosed as T1. He hates needles and finger pricks - so HELL YES we are interested, especially with all the other benefits Afrezza offers.

    Posted by Mark |
  18. I’ve looked into exubra and Mannkind’s Afrezza. The similarities stop at them both being inhalable. A couple points.

    1. The premise of the question is not accurate. The exubra users that were found with lung cancer were lifetime smokers. There’s yet to be any link between Exubra and cancer and statistically, you would find more people with lung cancer in any group of people vs the percentage of exubra users that were found w/ the cancer. I suggest you do your research before furthering unsubstantiated rumors off the internet. Nothing was proven and to undermine Afrezza and it’s potential positive impact on people’s lives does many people a disservice.

    2. Someone mentioned the simplicity of injections. With injections you have to deal w/ titration. With afrezza, studies have been conducted in which people were given 100g carb meals and no carb meals while maintaining the SAME DOSE. There was no incidents of hypoglycemia. That means very little if any titration. Part of the reason for this is how quickly it enters your system and how quickly it leaves. Afrezza more closely mimicks the profile of natural insulin in the body. The added benefit is less stress on the pancreas. The doubters may want to take a more close look at the product. I’m quite excited about it.

    3. The inhaler is the size of a WHISTLE. Discreet and disposable. In fact a previous commenter pointed out the reason for the FDA’s rejection was threefold: package labeling, clinical utility and a few questions about the new inhaler. Clinical utility speaks to how Afrezza would be used alongside other insulin therapies. No safety issues were raised and Mannkind was able to resubmit in about 60 days since the data was readily available.

    3. Additionally, in response to others’ concerns about lung cancer. As a result of Exubra, Mannkind did very extensive studies on humans and they’ve found zero incidents of lung cancer. I suppose that’s the one good thing that might come from Exubra: Mannkind being hypersensitive to lung cancer concerns. BTW - did anyone see the recent story about using an inhaled powder to cure lung cancer? Google it. I have ZERO concerns about lung cancer. It wasn’t proven w/ exubra and no human studies have shown any incidents in Afrezza. Do your homework, you won’t be sorry.

    4. It actually can go a week without needing to be refrigerated. A small detail but it just makes it easier on all of us.

    5. For those on the pump, you should know that the very guy that invented the insulin pump, Al Mann, is the founder of Mannkind. The guy knows diabetes. However, the pump is expensive.

    6. Pricing. AFAIK pricing was discussed with the large insurers over a year ago. Expect it to be within 5% of existing insulin therapies.

    7. The one thing I want to repeat for those that have already passed judgement is that exubra’s failure made it much easier for Afrezza. The company knew where to focus it’s testing. It now knows what worked and didn’t work and how to improve it. This is not the same insulin that exubra is. It’s vastly different and the two shouldn’t even be compared.

    8. I think if the FDA had lung cancer concerns they wouldn’t have asked Mannkind to reduce the age of their juvenile studies down to 4 years old….prior to approval. I can’t even imagine how this will help prediabetes patients as well as parents who would otherwise have to give multiple injections to their kids. I’ll set aside the implications of non-compliance in many others due to their distaste for needles.

    Last, I beleive the FDA will decide towards the end of December. I’m keeping my fingers crossed.

    Posted by pa card |
  19. My understanding is that AFREZZA almost exactly mimics the curve of natural insulin produced by a healthy individual, this basically eliminates any need for the complicated titration which Exubera seemingly required. Apparently, the only real side effects are a transient cough which goes away for most users after a week or two (approx. 3% of trial participants discontinued use due to this) and some minimal loss of lung funtion which is reversable upon cessation of use - the original inhaler by MNKD had aprrox. a 1.5% lung function reduction, but the newer inhaler which MNKD is now promoting seems to result in even less lung function loss. I agree with the previous poster as regards lung cancer - there really was no statistical increase with Exubera and there is no indication of such with AFREZZA either; the insulin moloecule isn’t metabolized in the lung tissue and apparently passes directly into the blood stream without an inflamatory response. This product borders on revolutionary in my opinion. So many diabetics are non-compliant as regards diet and insulin useage due to the dread of injections, even more so probably for children - this product sounds almost too good to be true; I think it will greatly increase overall quality of life for diabetics. Hopefully it will only be 5 or 10 percent more expensive than current standard of care as some are claiming - thus no insurance issues.

    Posted by Craig |
  20. Mannkind is on the right track. More and more people are diagnosed with Diabetes. Escaping the inoculations in favor of the inhaler is nothing less than a godsend.

    Posted by J.C. Mc Guire |
  21. being diagnosed with T1 at 1 and half i would love inhaled insulin. ive had a pump for a year now and nothing but problems. its really difficult to have an active teenage life when everytime you wrestle your site falls out or starts leaking. and wearing a bulky pump pouch in a prom dress! how embarrasing. let me know if i can be in the trial!!!

    Posted by Allison Thornton |
  22. i did a study using the inhaled insulin exubra, when they were testing it. thay wanted to see if there was any problem using it with asthma. i loved it. it was just as easy to use as shots and as easy to control my diatetes as shots. i was very disappointed when they scrapped it. i think it had a lot of potential.

    Posted by nancy holton |
  23. .I would love to try this new inhaled insulin. I used exubera for as long as I could get it. I did very well on the exubera.

    Posted by Retha Dean |
  24. YES…YES…YES…I started out as a Tyoe 2 four years ago..now a Type 1 The shots are definitely getting to me..I have fibroid build up at the injection sites…anything that would lower the number of injections per day would help…now I have at least 6 per day!! Plus I have a family history of Altzheimers and that worries me also. Any way to sign on for the clinical trials?

    Posted by Cheryl Brand |
  25. I also used Exubera for as long as it was available. I had excellent control of my diabetes with it. I think, as some have mentioned here, that it was not properly marketed to the public or medical professionals. It was a good product and I was very disappointed when it was removed from the market and I had to switch to injections.

    Afrezza does sound like an improved version. One thing though, someone mentioned the Afrezza needs some refrigeration? It seems to me that the Exubra did not?

    Still I am all for switching back to an inhalable insulin.

    I wonder if the savings on syringes or pen needles, and alcohol swabs will offset the price increase slightly?

    Posted by Catherine |
  26. I just looked at Mannkind’s press releases and they are still in trials but expect to submit for approval 3rd quarter 2013. http://www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1742098&highlight=

    Posted by Catherine |

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