Die Testimonials sind überwältigend und Sanofi wird mit diesen Aussagen bestimmt das Label erweitern, und wenn es mit neuen Trials nochmals 1 Jahr dauert, Afrezza ist der Konkurrenz überlegen:
Early Adopters Embrace Afrezza, As New Inhaled Insulin Enters Market
Mar. 23, 2015 9:31 AM ET | 19 comments | About: MannKind Corporation (MNKD)
Disclosure: The author is long "MNKD". (More...)
Summary
•Early adopters glowing with praise for Afrezza.
•Early adopters are experimenting in using the new inhaled insulin.
•Early adopters are exposing the limitations in the FDA designed clinical studies.
After less than eight weeks after pharmaceutical giant Sanofi's launch of MannKind's (NASDAQ:MNKD) designed Afrezza, first reports coming in from early adopters appear to be glowing with praise for the new inhaled insulin. While we are looking at only a handful of early adopters so far, Afrezza is being touted as being responsible for bringing diabetic blood glucose numbers back down into normal non-diabetic range.
Early adopter, Eric Fenar, writes on his Twitter page,
“
Showed my PCP Dr. my CGM #s & this was his reply, 5.5 holy cow! My original goal was <6.3.
His doctor also wrote in a message to his patient,
“
Fantastic, I am very excited about this new possibility.
Sam Finta, a Type 1 diabetic who took part in the Food And Drug Administration's designed Afrezza clinical trials and possibly the first person to use and write about Afrezza after launch, states on his Twitter page in regard to his blood glucose numbers,
“
Best day on Afrezza today. 3 meals today without a spike. I spent 88% of the day between 75-125 mg. I am speechless!
Controversy has risen in regard to the F.D.A. trials and pundits believe that the F.D.A. seemingly handicapped the inhaled insulin as the trials were set up so that Afrezza would be taken in a manner similar to injected insulin for comparative purposes in order to ascertain Afrezza as "non inferior", but early adopters are using the new inhaled insulin in ways other than what was designed by the FDA for the clinical trials.
This fine tuning now includes taking Afrezza during and after meals, sometimes more than once, and not before meals as is commonly the practice with injected insulin that takes much longer to enter and leave the body.
An early adopter calling herself, I'm_typeone, on a forum called Diabetes.co.uk writes,
“
I wait 10-15 mins after [eating] before taking the Afrezza to time the insulin with the sugar peak. Sometimes I take 8u with the meal with a 4u later if I start to see a rise. It's funny, (I am on a cgm) now when I see a 170 and rising I will react with insulin... Before I would be at 250 or higher before making an adjustment or correction for fear of stacking and crashing. I usually just look at the carb total in the meal... And dose based on that... And check again in an hour or so to see if an adjustment is needed.
Perhaps, one of the most striking developments and potentially one of the most valuable aspects of Afrezza is the possibility that using the inhaled insulin will help diabetics use less insulin in their treatment of their disease.
Sam Finta in his blog, afrezzauser.com, writes,
“
I noticed that 2 weeks into my treatment that my requirements for insulin dropped significantly even as a type 1 . The only explanation I had is that I was more insulin sensitive. From my own research, I have learned that any abnormal levels of sugar can build up insulin resistance in type 1 and type 2. For someone who has had horrible A1C readings it can definitely cause insulin resistance. On my trials, I dropped my A1c to 6.8 and finished at 7.1 from a start of 8.5. An A1c of 6.8 is definitely "diabetic", so I really did not notice anything drastic about my insulin use dropping my A1c levels to around 7 on my trials. As I mentioned before, we were held back and limited in dosing and in what we could do for our insulin use which does not match a true "real world" experience.
The idea of using Afrezza to reduce pre-meal morning spikes is another possible innovation in the use of the new inhaled insulin. Another early adopter going by the name, MikeP, and posting on March 1st at the blog, TuDiabetes.org writes,
“
One thing I wanted to mention is that I woke up at 1:48 this morning, so I decided to inhale 4u of Afrezza as a correction. The Afrezza kicked in very quickly. I took it at 8:52am and by 9:15am I was down in the 90s. It's now 10:30 and I have not hypo'd. Interesting.
In response to MipeP's message, another writer named Terry, replied,
“
Incredible landing! And, fast too. The more I read, the more excited I get. I think Afrezza will be better than I hoped.
However, not all of the experimenting has gone perfectly. Another early adopter, going by the name of Pat, who previously had asthma as a teenager, wrote on March 18th in his blog,
“
Taking a puff of albuterol before doing an afrezza inhale causes me zero discomfort or wheezing. I don't mind doing this occasionally, but unless I am able to stop the wheezing exhibited from using afrezza without the albuterol, I am not sure it can ever be my primary source of insulin.
Pat went on to follow up on March 20th,
“
The only real issue I still have is the slight breathing issues with Afrezza (see older post). I've been using my inhaler pre afrezza inhalation (for more than 8U), and that's made the issue go away. I wish this wasn't the case, but afrezza is so amazing that I am willing to do this.
Early adopters are often the eyes and ears for a company that spends millions, or in this case, more than a billion dollars on research and development of a potentially game changing technology. Early adopters are the people who use their brains in ways that others could not have foreseen prior to the early adopter's use of the product. With all the noise related to investment analysis of recent days, it may be prudent to focus on what may actually be the most important development of the past few weeks, the idea that Afrezza is being warmly embraced and that early adopters are finding innovative ways to use the inhaled insulin and through their efforts they will eventually be of help to millions of people.
One last point and this is very important: I suggest that readers can follow the early adopters where they are publicly writing about their experimentation and innovation, but unless you are a member of the diabetic community, respect their right to refrain from dialogue with non-diabetics if that is their wish.
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