|
Post by peppy on Feb 21, 2017 15:45:56 GMT -5
MNKD/Mannkinds' new sales team starts implementing their sales plans today. Hopefully daily luncheons at physician offices. (The one's that still do that) Over a year since Sanofi dropped Afrezza. Mannkind still alive.
The clamp study is going to save us. www.mannkindcorp.com/Collateral/Documents/English-US/Baughman%20poster%20100-LB%20FINAL%20X2.pdf
Afrezza is the most rapidly absorbed rapid-acting insulin on the market. The insulin concentration from Afrezza peaks at Tmax in approximately 12 to 15 minutes and returns to near baseline in about 3 hours (FIGURE 1a).2,3 In contrast, the concentration of SC rapid-acting insulin analog (SC RAA) peaks at Tmax in about 45 to 60 minutes and can remain elevated for more than 5 hours.
If the healthcare provider and patient do not titrate the dose to an adequate blood glucose control, they might believe it does not work.
ajmc.s3.amazonaws.com/_media/_pdf/EBDM0916.pdf DISCLOSURES Author Information: The author retired from the Washington State University College of Pharmacy in 2013 after 45 years and remains a distinguished professor emeritus of pharmacotherapy. He has lived with type 1 diabetes for 67 years and has used an insulin pump for 37 years, 9 months. Disclosures: The author serves on the advisory board on insulin for Novo Nordisk.
|
|
|
Post by dreamboatcruise on Feb 21, 2017 16:57:37 GMT -5
peppy... one would think doctors with patients that have problems with delayed post prandial hypos would understand the benefits if shown the clamp data. Will be interesting to see if the consumer messaging will try to convey a benefit from faster Pk/pd and how specific they can be. Can't wait for the "time in range" trials to happen. I think that is a message that would be simple to convey in DTC advertisements. The clamp studies did point out the drawback of settling on calling Afrezza doses "units". Exubera wasn't units and that was cited as a problem, but with such a big difference in pd between an Afrezza "unit" and a lispro "unit", maybe it would have been better to not call them units. They paint this mismatch as being conservative for safety, but it does seem this has been an issue as you point out... and SNY probably did nothing to educate docs on titration.
|
|
|
Post by buyitonsale on Feb 21, 2017 17:02:06 GMT -5
Physicians will listen, read, shake hands and continue with what they believe. Most will see it for the first time and will not consider prescribing for at least a year (for the novelty reason alone).
Sales team should split their efforts to 50% doctors and 50% patient awareness. Have workshops with patients. Without patient driven demand there will be no new RXs.
In order for the internal sales team to make a difference, they need new initiatives and promotion tactics, not just new faces.
Otherwise we will see the same results as in the last 6 months.
I hope DTC advertising starts sooner rather than later.
|
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Feb 21, 2017 17:05:35 GMT -5
Physicians will listen, read, shake hands and continue with what they believe. Most will see it for the first time and will not consider prescribing for at least a year (for the novelty reason alone). Sales team should split their efforts to 50% doctors and 50% patient awareness. Have workshops with patients. Without patient driven demand there will be no new RXs. In order for the internal sales team to make a difference, they need new initiatives and promotion tactics, not just new faces. Otherwise we will see the same results as in the last 6 months. I hope DTC advertising starts sooner rather than later. But mankind sales team like to do the same thing again and again with Sanofi , mannkind 2.0 and 3.0 Did you email management and let them know your thoughts?
|
|
|
Post by peppy on Feb 21, 2017 17:23:16 GMT -5
Physicians will listen, read, shake hands and continue with what they believe. Most will see it for the first time and will not consider prescribing for at least a year (for the novelty reason alone). Sales team should split their efforts to 50% doctors and 50% patient awareness. Have workshops with patients. Without patient driven demand there will be no new RXs. In order for the internal sales team to make a difference, they need new initiatives and promotion tactics, not just new faces. Otherwise we will see the same results as in the last 6 months. I hope DTC advertising starts sooner rather than later. But mankind sales team like to do the same thing again and again with Sanofi , mannkind 2.0 and 3.0 Did you email management and let them know your thoughts? our thoughts are easy enough to read. they are front and center.
If the healthcare provider and patient do not titrate the dose to an adequate blood glucose control, they might believe it does not work. ajmc.s3.amazonaws.com/_media/_pdf/EBDM0916.pdf DISCLOSURES Author Information: The author retired from the Washington State University College of Pharmacy in 2013 after 45 years and remains a distinguished professor emeritus of pharmacotherapy. He has lived with type 1 diabetes for 67 years and has used an insulin pump for 37 years, 9 months. Disclosures: The author serves on the advisory board on insulin for Novo Nordisk
added: The pharmacologist above just told us what is/has happened to refills. "If the healthcare provider and patient do not titrate the dose to an adequate blood glucose control, they might believe it does not work. ajmc.s3.amazonaws.com/_media/_pdf/EBDM0916.pdf "
The physicians didn't know how to titrate.
|
|
|
Post by dreamboatcruise on Feb 21, 2017 18:12:47 GMT -5
Physicians will listen, read, shake hands and continue with what they believe. Most will see it for the first time and will not consider prescribing for at least a year (for the novelty reason alone). Sales team should split their efforts to 50% doctors and 50% patient awareness. Have workshops with patients. Without patient driven demand there will be no new RXs. In order for the internal sales team to make a difference, they need new initiatives and promotion tactics, not just new faces. Otherwise we will see the same results as in the last 6 months. I hope DTC advertising starts sooner rather than later. I don't think FDA would approve of having sales people without medical credentials putting on workshops for patients. That would be something that would require the nurse educators at a minimum. I'd also question how many PWD would sign up for a workshop about a drug. That's quite a commitment of time. Having MNKD present at already scheduled diabetes community events would likely get a lot more exposure.
|
|
|
Post by peppy on Feb 21, 2017 20:24:17 GMT -5
But mankind sales team like to do the same thing again and again with Sanofi , mannkind 2.0 and 3.0 Did you email management and let them know your thoughts? our thoughts are easy enough to read. they are front and center.
If the healthcare provider and patient do not titrate the dose to an adequate blood glucose control, they might believe it does not work. ajmc.s3.amazonaws.com/_media/_pdf/EBDM0916.pdf DISCLOSURES Author Information: The author retired from the Washington State University College of Pharmacy in 2013 after 45 years and remains a distinguished professor emeritus of pharmacotherapy. He has lived with type 1 diabetes for 67 years and has used an insulin pump for 37 years, 9 months. Disclosures: The author serves on the advisory board on insulin for Novo Nordisk
added: The pharmacologist above just told us what is/has happened to refills. "If the healthcare provider and patient do not titrate the dose to an adequate blood glucose control, they might believe it does not work. ajmc.s3.amazonaws.com/_media/_pdf/EBDM0916.pdf "
The physicians didn't know how to titrate.
ad nauseam, (you all know) Mike C knows. Below is what Ray said in last November in the third quarter conference call:
We recently conducted an advisory board leading to identify ways to enhance and simplify the initiation of Afrezza in clinical practice. At the ad board they resoundingly felt that Afrezza differentiated pharmacokinetic profile made it an invaluable option for treatment of diabetes. Afrezza clears offers advantage to keep patients within a tight glucose target range, potentially leaning to less hyper and hyperglycaemias episodes. To accomplish this, however, the proper dosing and titration of Afrezza is a paramount importance because this is one of the areas that we have seen where healthcare providers struggle.
To address these issues we are planning a 12-week to 16-week time and range dose optimization study in type 1 diabetics using CGM with Dexcom or the new Abbott Libre system. This study will be conducted in three to five of the most well-respected institutions in the country, adding credibility to the data and providing an immediate impact on clinical practice. We expect study start up to begin in the first quarter of 2017 with results sometimes in the fourth quarter.
Additionally, we are planning a short pilot study for patients with type 2 diabetes that will allow us to simplify dosing initiation and titration. This will help patients get to the optimal dose quickly and effectively.
Once again, there is/was our refill problem. Management knows.
|
|
|
Post by peppy on Feb 22, 2017 7:56:31 GMT -5
peppy is still working through, "shock" once more. Picking up the story in my mind, so sanofi makes a deal with Mannkind to market afrezza. Which group came up with the packaging? Who came up with one box with 90 4 unit cartridges? then the 60 4 unit and 30 8 unit combo the 60 8 unit and 30 4 unit combo Mannkind nor Sanofi knew how to titrate. looks a bit obvious now. "If the healthcare provider and patient do not titrate the dose to an adequate blood glucose control, they might believe it does not work." ajmc.s3.amazonaws.com/_media/_pdf/EBDM0916.pdf "To accomplish this, however, the proper dosing and titration of Afrezza is a paramount importance because this is one of the areas that we have seen where healthcare providers struggle." Mannkind conference call. What happened to refills? Diabetes not prescribed enough Afrezza to do the job. Now we know. hcp.afrezza.com/afrezza-configurations/
|
|
|
Post by peppy on Feb 23, 2017 11:29:27 GMT -5
peppy is still working through, "shock" once more. Picking up the story in my mind, so sanofi makes a deal with Mannkind to market afrezza. Which group came up with the packaging? Who came up with one box with 90 4 unit cartridges? then the 60 4 unit and 30 8 unit combo the 60 8 unit and 30 4 unit combo Mannkind nor Sanofi knew how to titrate. looks a bit obvious now. "If the healthcare provider and patient do not titrate the dose to an adequate blood glucose control, they might believe it does not work." ajmc.s3.amazonaws.com/_media/_pdf/EBDM0916.pdf "To accomplish this, however, the proper dosing and titration of Afrezza is a paramount importance because this is one of the areas that we have seen where healthcare providers struggle." Mannkind conference call. What happened to refills? Diabetes not prescribed enough Afrezza to do the job. Now we know. hcp.afrezza.com/afrezza-configurations/
The new titration pack, Matt also called it the flex pack. "So, we previously announced we were doing what we call flex packs or titration packs instead of 90 cartridges, 180 cartridges those were a combination of 4s and 8s. We are going to follow that with a 4, 8 and 12 pack like that to make it easier for people to titrate to the correct dose quickly and get the best possible results. Most of you know we did submit an FDA label change to better show the pharmacokinetics of the product and show that we really are an ultra-rapid acting insulin. We have PDUFA date in September. " seekingalpha.com/article/4036493-mannkinds-mnkd-ceo-matt-pfeffer-presents-jpmorgan-healthcare-conference-transcript?page=7 1440 total units of insulin. hcp.afrezza.com/afrezza-configurations/
|
|
|
Post by peppy on Feb 24, 2017 8:55:40 GMT -5
I am paying attention. Something that has caught my attention and I would like to talk about.
Afrezza is the most rapidly absorbed rapid-acting insulin on the market. The insulin concentration from Afrezza peaks at Tmax in approximately 12 to 15 minutes and returns to near baseline in about 3 hours (FIGURE 1a).2,3 In contrast, the concentration of SC rapid-acting insulin analog (SC RAA) peaks at Tmax in about 45 to 60 minutes and can remain elevated for more than 5 hours. The difference in pharmacokinetics (PK) translates into a difference in pharmacodynamics (PD): Afrezza’s glucose-lowering effect begins sooner and has a shorter duration than SC RAA.3 In the Affinity 1 trial, Afrezza demonstrated clinical noninferiority to SC RAA with significantly lower incidence of hypoglycemia,4 a clinically significant benefit for patients. Because Afrezza does its work early and then “gets out of the way,” the risk of late hypoglycemia (2 to 5 hours after the start of a meal) was markedly reduced, while postmeal glucose excursions were diminished. Patients who are motivated to manage their blood glucose levels through frequent monitoring—and who understand the effect of different doses of Afrezza—do extremely well when using it. Once a patient understands his or her individual dose response (eg, “a 4-unit cartridge reduces my glucose by 30 mg/dL in 90 minutes frequent blood glucose monitoring or continuous glucose monitoring provides data that can be acted upon quickly with little risk of “insulin stacking.” Several patients on pump therapy, who achieved glycated hemoglobin (A1C) of 7.5% to 8%, gave up the pump, switched to basal insulin injections and prandial (mealtime) Afrezza, and reached their A1C goal for the first time in years. The payoff for these patients is so great, both in terms of treatment success and the freedom from having to think about diabetes all the time, that they have become the biggest champions of Afrezza.
Here is my question. Using this information: “a 4-unit cartridge reduces my glucose by 30 mg/dL in 90 minutes" Knowing that afrezza keeps blood glucose from going high in the first place, Is it possible to come up with a carb count/units equation for afrezza? Just asking. ajmc.s3.amazonaws.com/_media/_pdf/EBDM0916.pdf
Then again part of the beauty of afrezza is no more carb counting?
|
|
|
Post by agedhippie on Feb 24, 2017 10:07:08 GMT -5
Here is my question. Using this information: “a
4-unit cartridge reduces my glucose by 30 mg/dL in 90 minutes" Knowing that afrezza keeps blood glucose from going high in the first place, Is it possible to come up with a carb count/units equation for afrezza? Just asking. ajmc.s3.amazonaws.com/_media/_pdf/EBDM0916.pdf
Then again part of the beauty of afrezza is no more carb counting?
The tricky bit is the fast clearance. With injected insulin the duration is long enough to cover the second phase, with Afrezza it sometimes isn't. Stacking is less of an issue than people think with either insulin. With a pump it's handled by the dose calculator which automatically accounts for remaining insulin and carbs. Stacking could be an issue with Afrezza if you take two doses close together - say the initial dose and then another one an hour later because you expect to need the second phase cover. Having said all that if I was using Afrezza I would calculate carbs as normal and then go for the next dose size up. I would want to verify that this works though because some of the CGM graphs people on Afrezza show definitely have hypos on them.
|
|
|
Post by peppy on Feb 24, 2017 10:13:03 GMT -5
post your continuous glucose monitor screens for a week. I want to see how high and low you are going.
those occasional sometimes once a day 70mg/dl's I see. Aged can you feel that?
On a side note, blood glucose running 70 mg/dl or below? drink an apple juice box. Eat an orange. Down a skittle.
I still want to see your screens.
|
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Feb 24, 2017 10:40:18 GMT -5
post your continuous glucose monitor screens for a week. I want to see how high and low you are going.
those occasional sometimes once a day 70mg/dl's I see. Aged can you feel that?
On a side note, blood glucose running 70 mg/dl or below? drink an apple juice box. Eat an orange. Down a skittle.
I still want to see your screens. that should tell the board how controlled Aged is , in addition to the effort he puts in it and the diet he has accustomed himself to achieve those levels
|
|
|
Post by agedhippie on Feb 24, 2017 11:01:27 GMT -5
post your continuous glucose monitor screens for a week. I want to see how high and low you are going.
those occasional sometimes once a day 70mg/dl's I see. Aged can you feel that?
On a side note, blood glucose running 70 mg/dl or below? drink an apple juice box. Eat an orange. Down a skittle.
I still want to see your screens. I can feel 70 most of the time. The trick is to tell if it's a real low or just hunger. I use Skittles or glucose tablets, they are faster than juices for me. Mostly it's Skittles though because they take longer to eat. The problem is I can eat my 15g of glucose really fast and then I have to wait 15 minutes which is hard, the temptation is to eat more because the glucose hasn't hit yet and your body is still ring the alarms. Skittles are fast but keep you occupied if you eat them individually so it burns time and makes overeating less likely. With a bad (for me) low in the 40s I have been known to try and eat the entire contents of the refrigerator - you go into a food frenzy and if a portion of ice cream is good then the entire tub must be excellent, oh and look there is a liter of juice, oooh biscuits... The ensuing high is bad, but the feeling of nausea from what you ate is worse My number have slipped - My year end A1c was 7.1 which is off from 6.3 before that. I need to get a new transmitter (yes I am idle) but once I have done that I will post some screens. I do much better on a CGM because it prods me to dose properly!
|
|
|
Post by agedhippie on Feb 24, 2017 11:06:12 GMT -5
post your continuous glucose monitor screens for a week. I want to see how high and low you are going.
those occasional sometimes once a day 70mg/dl's I see. Aged can you feel that?
On a side note, blood glucose running 70 mg/dl or below? drink an apple juice box. Eat an orange. Down a skittle.
I still want to see your screens. that should tell the board how controlled Aged is , in addition to the effort he puts in it and the diet he has accustomed himself to achieve those levels I'm a bad diabetic, although possibly more typical, in that respect. I tend to eat and bolus after the meal which is really not recommended. I also don't check at the two hour mark and correct. My aim is good enough rather than non-diabetic.
|
|