Afrezza inhaled fast acting insulin

mountainman · Mar 17, 2015

LaineyK said:
As I said in my earlier post, I do hope Afrezza comes over here and it looks promising. I think there is a lot of paranoia out there these days about pharmaceutical financial gain. We will have to wait for NICE to make their findings, hope it's passed soon. I wonder if it will be available on prescription, this or next year.

I see the paranoia , as you stated. The negativism on this board is enough to make anyone run for the hills. Back in the real world though, progress is really being made . I look forward to continuing to follow NICE and their findings. I look at their site every couple weeks to see the status for the 3ed clinical trial. This is very exciting that it is getting so close to the last step before approval in the UK - better health coming soon !!

tim2000s · Mar 17, 2015

I guess the point is @mountainman, we don't trust you. You act like a classic investor spammer, pumping up the new best thing for diabetes and have shown nothing to demonstrate your credibility. We have no experience of you.

Yes the product is very interesting and the pharmakinetics are very different from existing insulins. I very much doubt that some of the effects were expected during the development, indeed reading the early details suggests simply a more efficient mechanism to deliver insulin without use of a needle. That gluconeogenesis is effectively turned off is a welcome side effect.

I still have reservations over the long term effects of inhaling powder into your lungs, even if it is supposed to convert to a liquid form on contact. From what I can see of the testing, the longest term in the trials was about two years.

I welcome the opportunity to try it out but given the ease of access we are likely to see here if NICE approval is given, few of us in the UK get too excited until it is actually here. As I've said before, we've been diabetic too long and seen miracle treatments too many times.

pinewood · Mar 18, 2015

Wow, a lot of pessimism on this thread. Maybe that's what happens when you've had T1 for a long time and have been disappointed by "breakthroughs" in the past. However, I am still keen to try to this and hope it makes its way on to the NHS soon. For those asking about "real life" experiences by "real people" you only need to search Twitter to see literally hundreds of remarkable, real-life, non-endorsed experiences. The verdict is out, and it is extremely positive so far.

donnellysdogs · Mar 18, 2015

pinewood said:
Wow, a lot of pessimism on this thread. Maybe that's what happens when you've had T1 for a long time and have been disappointed by "breakthroughs" in the past. However, I am still keen to try to this and hope it makes its way on to the NHS soon. For those asking about "real life" experiences by "real people" you only need to search Twitter to see literally hundreds of remarkable, real-life, non-endorsed experiences. The verdict is out, and it is extremely positive so far.

May be because of a long time T1. Its not pessimism but the enthuse for the product isn't balanced to my way of thinking. I can enthuse over my Insight pump all day long compared to other pumps on the market.. But I can also tell people that it isn't perfect. Not because I'm negative or pessimistic but I like people to be anle to get a balance of just what the pro's and cons could possibly be to others.

The posting is full on, in your face positiveness which is ok if it really is100% a miracle drug to save the diabetic world... But something is just not balanced to me with the hype...

However I do believe the financial aspects of drug companies and their dirty games.. As all they see are profits...

tim2000s · Mar 18, 2015

pinewood said:
Wow, a lot of pessimism on this thread. Maybe that's what happens when you've had T1 for a long time and have been disappointed by "breakthroughs" in the past. However, I am still keen to try to this and hope it makes its way on to the NHS soon. For those asking about "real life" experiences by "real people" you only need to search Twitter to see literally hundreds of remarkable, real-life, non-endorsed experiences. The verdict is out, and it is extremely positive so far.

Not so much pessimism as a huge dose of reality. The last "amazing" inhaled insulin was withdrawn from the market after two years following the determination that it caused lung cancer.

The long term effects of inhaled treatments take a long time to show up. While the animal tests seem to show no signs of changes to pulmonary cells and those who undertook the trials seem not to be affected, no-one knows what five or ten years will do.

As I've said, I'd certainly be willing to try it out. The pharmakinetics are interesting, but equally the claims that I've seen feel like they are too good to be true. Usually there is a catch and if in this case there isn't one, then great!

I'd take the view as being positive relating to the product, but perhaps less so relating to the poster!

Scardoc · Mar 18, 2015

I've not had time to read all of this thread but commented on this story on another thread a month or two back. From memory, the American health body (can't remember the initials!) approved it's use but strictly on the condition that there were significant trials carried out to determine the effect it has on the lungs and that the UK was stepping back until such time.

Definitely a 50/50 case of optimism vs pessimism for me.

Billytrack · Mar 18, 2015

Scardoc said:
I've not had time to read all of this thread but commented on this story on another thread a month or two back. From memory, the American health body (can't remember the initials!) approved it's use but strictly on the condition that there were significant trials carried out to determine the effect it has on the lungs and that the UK was stepping back until such time.

Definitely a 50/50 case of optimism vs pessimism for me.

I think it actually says on the Afrezza website that it (from memory) 'may damage lungs'. For me, if that was minor and that was the only problem with it, I would still bite the hand off them to get it.

I really hope it's as good as reports suggest.

donnellysdogs · Mar 18, 2015

Billytrack said:
I think it actually says on the Afrezza website that it (from memory) 'may damage lungs'. For me, if that was minor and that was the only problem with it, I would still bite the hand off them to get it.

I really hope it's as good as reports suggest.

Having seen how badly COPD and asbestosis affects people there is no way I would have anything that could damage lungs. No way. No matter if it did ease injections etc.having been on insulin for 30 years and no complications why would I want to risk my breathing. How can any damage to lungs be minor even whether it is a minority of people or minor damage?
If you damage lungs then that is not good.

We all know from asbestosis etc that damage is not necessarily immediate. My uncle died the most awful, excruciating death from it 40 years after handling it.. Me personally I won't be joining the queues to get it.

shaggy1974 · Mar 18, 2015

donnellysdogs said:
Having seen how badly COPD and asbestosis affects people there is no way I would have anything that could damage lungs. No way. No matter if it did ease injections etc.having been on insulin for 30 years and no complications why would I want to risk my breathing. How can any damage to lungs be minor even whether it is a minority of people or minor damage?
If you damage lungs then that is not good.

Totally agree! I was excited because of the reduced hypos but I'm not willing to risk damaging my lungs. Especially when we already have a pretty efficient way getting insulin into our systems as it is

catherinecherub · Mar 18, 2015

http://www.fiercepharma.com/press-r...afrezza-only-inhaled-insulin-now-available-In
In addition to low blood sugar (hypoglycemia), other possible side effects associated with Afrezza include cough, throat pain or irritation, headache, diarrhea, tiredness, and nausea

http://www.drugs.com/pro/afrezza.html

Decline in Pulmonary Function
Afrezza causes a decline in lung function over time as measured by FEV1. In clinical trials excluding patients with chronic lung disease and lasting up to 2 years, Afrezza-treated patients experienced a small [40 mL (95% CI: -80, -1)] but greater FEV1 decline than comparator-treated patients. The FEV1 decline was noted within the first 3 months, and persisted for the entire duration of therapy (up to 2 years of observation). In this population, the annual rate of FEV1decline did not appear to worsen with increased duration of use. The effects of Afrezza on pulmonary function for treatment duration longer than 2 years has not been established. There are insufficient data in long term studies to draw conclusions regarding reversal of the effect on FEV1after discontinuation of Afrezza. The observed changes in FEV1 were similar in patients with type 1 and type 2 diabetes.

Assess pulmonary function (e.g., spirometry) at baseline, after the first 6 months of therapy, and annually thereafter, even in the absence of pulmonary symptoms. In patients who have a decline of ≥ 20% in FEV1 from baseline, consider discontinuing Afrezza. Consider more frequent monitoring of pulmonary function in patients with pulmonary symptoms such as wheezing, bronchospasm, breathing difficulties, or persistent or recurring cough. If symptoms persist, discontinue Afrezza. [see Adverse Reactions

Scardoc · Mar 18, 2015

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm403122.htm

Here's what I read some time ago.

mountainman said:
The social enigma of syringes if one thing, agreed, but how Afrezza acts in a person's system in BY FAR the biggest part of this medication. Forget everything you know about insulin and start all over, because Afrezza is NOT LIKE ANYTHING ELSE ON THE MARKET. Can you imagine not having to do intense carb counting ?( although some would be smart ) . Can you imagine not having to concern your self with hypoglycemia ? Afrezza is REAL TIME INSULIN - acts as the pancreas does, no need to eat again in 3 hours after taking your injection. Little to no worries about going into a low, less to no weight gain as there is no need to eat again as with injectables since they are in your system for 5 hours, while Afrezza has done its work and is gone in 2 1/2 hours. With Afrezza if a person has a continuous glucose monitor and becomes aware they are going high, 4 U Afrezza can have it under control in a half hour.

@mountainman
I do think the quote above stinks of a sales pitch and, more seriously, a lack of knowledge and understanding of diabetes. Period (as they say in the USA).

The bottom line for me is that this drug is purely a faster acting fast acting insulin.

What any T1 diabetic will tell you is quite simple. We cannot produce insulin thus we inject it. We need to know how the food we are eating effects our BG levels. We need to know how much insulin is required to counteract this. We need to know when to take the insulin to have the maximum effect.

All the sales pitches in the world will not change the facts above and they are grossly over-simplified.

Yes, the product sounds great. Will it change my daily life as a T1 diabetic? I don’t think so. If I eat a carb heavy meal I can’t just say, ok 4U inhaled, sorted. I’d hypo 20mins later. I would need to wait until the delayed spike was due and then take it. Yes, over time you would learn but your comments are far too simplistic and frankly dangerous regarding hypos.

“A Review of Inhaled Technosphere Insulin”, Neumiller, Campbell & Wood found a greater incidence of hypoglycaemia in the trials of T2 diabetics using Technosphere compared to regular brand fast acting insulin. Not just in the initial 6 months, it increased in time over a four year study.
What people who don’t live in the diabetic world can’t understand is the complexity of the condition and how many factors come into play. This is not replicating the pancreas. If you want to make that claim then you need a product which can be in the system and kick in when BG level rises just as the pancreas does. There is one in production if you look for it.

I said earlier I had 50% optimism for this product, I think there could be great benefits for something which acts so quickly, I really do. However, I think your comments are seriously flawed.

Billytrack · Mar 18, 2015

Scardoc said:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm403122.htm

Here's what I read some time ago.

@mountainman
I do think the quote above stinks of a sales pitch and, more seriously, a lack of knowledge and understanding of diabetes. Period (as they say in the USA).

The bottom line for me is that this drug is purely a faster acting fast acting insulin.

What any T1 diabetic will tell you is quite simple. We cannot produce insulin thus we inject it. We need to know how the food we are eating effects our BG levels. We need to know how much insulin is required to counteract this. We need to know when to take the insulin to have the maximum effect.

All the sales pitches in the world will not change the facts above and they are grossly over-simplified.

Yes, the product sounds great. Will it change my daily life as a T1 diabetic? I don’t think so. If I eat a carb heavy meal I can’t just say, ok 4U inhaled, sorted. I’d hypo 20mins later. I would need to wait until the delayed spike was due and then take it. Yes, over time you would learn but your comments are far too simplistic and frankly dangerous regarding hypos.

“A Review of Inhaled Technosphere Insulin”, Neumiller, Campbell & Wood found a greater incidence of hypoglycaemia in the trials of T2 diabetics using Technosphere compared to regular brand fast acting insulin. Not just in the initial 6 months, it increased in time over a four year study.
What people who don’t live in the diabetic world can’t understand is the complexity of the condition and how many factors come into play. This is not replicating the pancreas. If you want to make that claim then you need a product which can be in the system and kick in when BG level rises just as the pancreas does. There is one in production if you look for it.

I said earlier I had 50% optimism for this product, I think there could be great benefits for something which acts so quickly, I really do. However, I think your comments are seriously flawed.

I agree with a lot of what you say, but I think it's wise to wait and see. I also have no idea how they would get round the carb heavy meal problem, and although I've seen videos that suggest it's not a problem, I can't figure out how that could be the case.

I am on a pump, and while it's good, it certainly isn't as good as I need it be. Too many variables, too much to get wrong. That's why I would like to see something else that I can try to control my diabetes a bit better.

Billytrack · Mar 18, 2015

catherinecherub said:
http://www.fiercepharma.com/press-r...afrezza-only-inhaled-insulin-now-available-In
In addition to low blood sugar (hypoglycemia), other possible side effects associated with Afrezza include cough, throat pain or irritation, headache, diarrhea, tiredness, and nausea

http://www.drugs.com/pro/afrezza.html

Decline in Pulmonary Function
Afrezza causes a decline in lung function over time as measured by FEV1. In clinical trials excluding patients with chronic lung disease and lasting up to 2 years, Afrezza-treated patients experienced a small [40 mL (95% CI: -80, -1)] but greater FEV1 decline than comparator-treated patients. The FEV1 decline was noted within the first 3 months, and persisted for the entire duration of therapy (up to 2 years of observation). In this population, the annual rate of FEV1decline did not appear to worsen with increased duration of use. The effects of Afrezza on pulmonary function for treatment duration longer than 2 years has not been established. There are insufficient data in long term studies to draw conclusions regarding reversal of the effect on FEV1after discontinuation of Afrezza. The observed changes in FEV1 were similar in patients with type 1 and type 2 diabetes.

Assess pulmonary function (e.g., spirometry) at baseline, after the first 6 months of therapy, and annually thereafter, even in the absence of pulmonary symptoms. In patients who have a decline of ≥ 20% in FEV1 from baseline, consider discontinuing Afrezza. Consider more frequent monitoring of pulmonary function in patients with pulmonary symptoms such as wheezing, bronchospasm, breathing difficulties, or persistent or recurring cough. If symptoms persist, discontinue Afrezza. [see Adverse Reactions

I don't think there's any drug I have taken that hasn't had a list of side effects as long as your arm! That said, if it's too bad, you just wouldn't take it.

phoenix · Mar 18, 2015

amusing
http://mnkd.proboards.com/thread/1987/diabetes-uk-afrezza-discussions

alaska · Mar 18, 2015

A key point about Afrezza is that whilst its time to peak insulin level is very quick -see graph B
http://images.rxlist.com/images/rxlist/afrezza2.gif

Its action on blood glucose levels is not (the glucose infusion rate (GIR)) -see graph A in the .gif file in the link

Put simply, much of the insulin inhaled gets into your bloodstream within 15 minutes but it's actually not that much quicker to improve BG levels than injected insulin.

Note also that the area under the curve for Afrezza is much smaller, so you need to take a larger dose of Afrezza than you do of an injected dose. This is presumably the reason why Afrezza advise rounding the dose UP to the nearest block of 4 units. I'd be interested to see how glucose levels respond for larger doses of insulin (eg 16 units plus).

I gather this is one of the reasons why, in clinical trials, Afrezza users had, in real terms, inferior HbA1c results.

Ali H · Mar 18, 2015

Be interesting to see how this develops, I for one hate injecting and to not have to do most of my injections each day would be brill. No chance of a pump and with the NHS in terminal decline there really is no chance, so unless something like this proves effective, I am stuck on Basal/Bolus forever.

Ali

tim2000s · Mar 18, 2015

Had an interesting chat with the research analyst that covers health and Sanofi in particular. This isn't something that anyone in equity research is paying much attention to.

Most consider Afrezza a niche product and there is real concern that the introduction of a growth agent in to the lungs will cause similar issues to Exubera. There is some surprise that nothing has been found yet. What surprised them more was that Sanofi have gone back into inhalable insulin.

I have a different theory on the tie up with MannKind. I wonder if, in the face of the new faster acting insulin aspart that Novo is currently undergoing clinical trials with, Sanofi have some kind of agreement to use the monomer based insulin that MannKind are creating in an injectable. This would provide them with a faster rapid insulin and may overcome what seem to be significant concerns relating to lung issues. All speculation of course.

PaulinaB · Mar 18, 2015

Hmmm... maybe this thread should be closed? A lot of medical information about this new product has been put in (if anyone is going to be looking for info about it) and I don't see much point in giving marketing people more space for SEO...

AfrezzaUser · Mar 18, 2015

I have been on Afrezza since 1/28/15. I was on the trials and spoke at the FDA. I have been averaging a non-diabetic 104mg the last 15 days and averaged 95mg before my last doctors visit. I am a type 1 for 16 years and have not counted carbs while on Afrezza. I am taking 28U of Lantus per day in a split dose and I am on a Dexcom CGM. I do not get paid by anyone to spread my message. I am an advocate for Afrezza because it has changed my life. I live and feel like I do not have diabetes for the 1st time in 16 years. I have attached a snapshot of my Dexcom results for the last 15 days. I have a website and twitter account where people can keep up with my results. Anyone has any questions please let me know.

Bsharp6669 · Mar 18, 2015

My name is Brian. I also use Afrezza. I am not an investor in anything....wish I was... the money they spend on OUR medical needs is the only reason any of us have any insulin to begin with.

I've been using Afrezza for a few weeks now and my results are incredible. My last A1c when I was on Humalog was 10.1 and my A1c that will be entirely Afrezza may be below 6. If it's not below 6 it will be really close to it.

I have had excellent control with Afrezza. It doesn't work anything like any other insulin I've ever used. Right when I 1st started using it I joined a thread very much like this one. I was attacked constantly, called a liar, an investor and so forth.... It was a really bitter experience for me. I'm not going through that again just for posting my amazing results I have. What I am going to do is continue to live my life using Afrezza and having Non-diabetic like readings everyday. I may not live forever, but I will live like a Non-diabetic from now on.

Afrezza does so much more than just be a fast acting super easy to use insulin. It's been a life changer for me. I hope it gets approved in the U.K. so it can change some lives with you as well!

I wish you all the best of health and happiness!

Brian

Afrezza inhaled fast acting insulin

Well-Known Member

Expert

Well-Known Member

Master

Expert

Well-Known Member

Active Member

Master

Well-Known Member

catherinecherub

Guest

Well-Known Member

Active Member

Active Member

Expert

Well-Known Member

Well-Known Member

Expert

Well-Known Member

Newbie

Attachments

Newbie

Privacy & Transparency

Privacy & Transparency