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Post by seanismorris on Apr 20, 2016 13:48:19 GMT -5
Interesting comment on expiring = ineffective drugs
Ideally someone would use the inhaler 99% of the time...but that means they are holding on to a useless pen for the one time they need it.
Bundling the inhaler and pen would be complicated...(in this situation).
I'm assuming the pen usage would be by someone else because the patient is unconscious.
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Post by end2war on Apr 20, 2016 14:05:50 GMT -5
Again, off the cuff, I think that the inhaled epi has great appeal and would turn out to be the main thing most carry after they have been used for some time and proven to work. One of the big advantages of the inhaled version is that people would use it a lot more than a needle, as a protective measure or whenever they think they might have ingested a potential allergent. It would be a far better way to protect because it eliminates the undesired injection that might not be needed. I would venture a guess that the inhaled version would be used as much as 10 times more than the injectable version once its benefits are known and understood.
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Post by lakon on Apr 20, 2016 14:10:16 GMT -5
Contemplate the Strategy MNKD knows all too well about how the FDA/BP operate. I like Ike. MNKD is clearly learning how to deal with the system. Epinephrine to treat Anaphylaxis is a brilliant strategy because it is both a legitimate unmet medical need, a huge market, and a fast track mechanism in the system. I love it! A keen eye would ask: What else does Epi treat? What else can Epi treat? Well, treating asthma attacks is another big market, but wait, there's more. One of the most successful treatments, Primatene Mist, was taken off the market. What? Wait a minute... Yes, it's true. "Epinephrine CFC metered-dose inhalers used to treat asthma (known as Primatene Mist or Epinephrine Mist) cannot be made or sold in the United States after December 31, 2011." www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm080427.htmHmm, wow! Now, who is responsible for this? Well, some are more culpable than others, but truth be told, if you really want to know, you need only look in the mirror... Anyway, fear not, "Albuterol HFA inhalers are safe and effective for these FDA approved uses: treatment or prevention of bronchospasm in patients with reversible obstructive airway disease, including asthma and chronic obstructive pulmonary disease (COPD)." How interesting. Well, it gets better folks. Who makes these things? Well, as it turns out, it is a rather significant technical challenge that MNKD's supplier, and dare I say partner, AMPH has taken on. AMPH owns the brand, Primatene Mist. They are working on a new formulation to bring it back on the market. They also have an Albuterol dry powder. The plot thickens. www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/NonprescriptionDrugsAdvisoryCommittee/UCM386676.pdfclinicaltrials.gov/ct2/show/NCT02210806medlibrary.org/lib/rx/meds/albuterol-1/page/4/
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Post by liane on Apr 20, 2016 14:17:47 GMT -5
Thanks lakon, I was aware of the general Primatene Mist story, but was unaware of the AMPH connection. The plot does indeed thicken.
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Post by lakon on Apr 20, 2016 14:28:25 GMT -5
Interesting comment on expiring = ineffective drugs Ideally someone would use the inhaler 99% of the time...but that means they are holding on to a useless pen for the one time they need it. Bundling the inhaler and pen would be complicated...(in this situation). I'm assuming the pen usage would be by someone else because the patient is unconscious. Very good and insightful comments. Here's my take. Several devices could be made, depending on the target audience. Most purchases would be for a key fob Epi inhaler -- better, faster, cheaper (actually used more often just-in-case). I mean would you really use an auto injector just-in-case? The naysayers need rethink their FUD, not you seanismorris, you brought up great points that can be resolved. The best part, hospitals can buy a lot more of the devices that they actually use, inhalers, and a lot less of the useless pens for the 1% chance. If this comes to pass, Mylan's market share declines, and MNKD's grows. A combo device could be designed for those who want the convenience, like patients that need to carry around both. Depending on the design, keeping the dry powder separate from the solvent could make it last longer, be more versatile, and provide options to the end user. On the other hand, it may be far cheaper to just make two separate devices with two different purposes and expiration dates. Who knows? Only MNKD knows. Either way, I don't see a solution as being too complicated, but you are correct that it must be addressed. I'm just spit balling here anyway. Sure the pen usage could be by someone else. That's very important. Also, a patient may not be able to inhale, but still inject so the more options the better the outcome.
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Post by lakon on Apr 20, 2016 14:36:49 GMT -5
Thanks lakon , I was aware of the general Primatene Mist story, but was unaware of the AMPH connection. The plot does indeed thicken. Yes, some folks on here prefer to only have black telephones, but I like options. AMPH is a great connection to have and a darn good investment to go with your MNKD if you ask me. They are tackling the heroin epidemic among other things. They also make the API [Epinephrine] so perhaps, they were real sweet on MNKD when renegotiating the insulin human API purchases...
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Post by seanismorris on Apr 20, 2016 14:48:20 GMT -5
OK...I admit it.
Thinking of MannKind dealing with th FDA frightens me.
The FDA came across as incompetent, and with a conflict of interest with regards to Afrezza.
One of the reasons I liked the Sanofi partnership is I though that they could 'fix' the relationship with the FDA.
I'd like see some deep pockets before facing that situation again. Getting approval but with another product killing label would be a waste of time.
I don't think anyon is arguing against the idea (of a TS version) but the cost.
On the bright side, no way is Matt going in blind this time. I sure he's going to analyze the heck out of any TS prospects (cost/benefit) before advancing them.
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Post by seanismorris on Apr 20, 2016 14:50:20 GMT -5
"Black Telephones"?
If they made them invisible I'd buy one...
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Post by lakon on Apr 20, 2016 15:01:45 GMT -5
Two more things and I'll call it a day for Epi.
1. How's this sound for Epi? 4U/8U - Asthma attacks 12U - Anaphylaxis (Pre-filled of course, but you get the idea. Nobody wants to be fumbling with cartridges when unable to breathe well.)
2. Now, Albuterol treats bronchospasm, too, such as caused by asthma and COPD. Epi can raise blood glucose levels. Somehow, these facts seem important to me...
MNKD actually studied Albuterol if you look hard at their site. Contraindications are not what they seem. You had better warm up your tin foil hat if you ask me, and giddy up!
I especially liked it when Hakan mentioned Nicotine Technosphere. That was the trifecta.
Foxtrot Tango Alpha
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Post by traderdennis on Apr 20, 2016 15:14:46 GMT -5
5a. Patients do not want to stab themselves with a needle. Really? Patients want to live another day. If diabetics who stick themselves multiple times per day don't see this as a huge issues, users of an epi pen certainly will not. Very flawed point. Just like California building a bullet train, sounds great when you hear the idea, but in reality we already have Southwest flying between LA and SF hundreds of times per day at a very reasonable cost. I'd take this point out.
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Post by lakon on Apr 20, 2016 15:33:31 GMT -5
5a. Patients do not want to stab themselves with a needle. Really? Patients want to live another day. If diabetics who stick themselves multiple times per day don't see this as a huge issues, users of an epi pen certainly will not. Very flawed point. Just like California building a bullet train, sounds great when you hear the idea, but in reality we already have Southwest flying between LA and SF hundreds of times per day at a very reasonable cost. I'd take this point out. Nah, I'd rather you keep re-reading the thread about 7 or so times. Eventually, you will get the point, or not. BTW, a bullet train is a good idea. Lots of other countries have proven the point. I need not bother, but I will say that a train holds a lot more passengers for a lot less money than any plane will. Good luck.
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Post by BlueCat on Apr 20, 2016 15:46:45 GMT -5
Ok. I am not (yet) in the Afrezza target market.
But here I am, and til recently, woulda qualified and signed up gratefully for trials, too. Thanks Peppy for flagging this, and Lakon for that thicker plot Liane refers too.
Primatene saved my life for years, when albuterol/ventolin appeared useless, and the only other option was years on steroids (and no, not the inhaled type. They were mostly useless for me too). And I carried said, large, evil, expiring needle. When Primatene got shut down, I spent a few years in serious bounce between danger and prednisone misery. Until I got Breo prescribed initially off-label.
I can tell you that a lot of asthmatics I know (and treating doctors) are aware that rescue inhalers these days just don't cut it. And clearly, if asthma were managed well for everyone (and this isn't always pilot error!) - there wouldn't be so many deaths.
There is a lot of potential here. And yea. The big stupid needle really sucks to carry around. Forget looking at sticking a darn railroad tie into your thigh, or, getting someone else to do it. And yea, you can go down fast. And sure - better than death. Problem is, when O2 gets short, decision-making skills and perception of time and balance start to warp out ...
And - Other than the refrigeration issue, gotta be up there with diabetic supplies - and worse because you typically need it when you are out somewhere in the middle of nowhere (see also bees and other things that bite).
I think its important to consider too that with Technosphere - not every drug needs to be immediate, global blockbuster status. They can make money on this in multiple directions, and do good too.
For those in the medical arena - think the TS formulation of epi would effectively open up those airways faster than primatene? That was fast, but it was like inhaling chlorine sometimes ....
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Post by liane on Apr 20, 2016 16:09:46 GMT -5
Two more things and I'll call it a day for Epi. 1. How's this sound for Epi? 4U /8U - Asthma attacks 12U - Anaphylaxis (Pre-filled of course, but you get the idea. Nobody wants to be fumbling with cartridges when unable to breathe well.) 2. Now, Albuterol treats bronchospasm, too, such as caused by asthma and COPD. Epi can raise blood glucose levels. Somehow, these facts seem important to me... MNKD actually studied Albuterol if you look hard at their site. Contraindications are not what they seem. You had better warm up your tin foil hat if you ask me, and giddy up! I especially liked it when Hakan mentioned Nicotine Technosphere. That was the trifecta. Just that the dosing would be something more like 0.1, 0.3, and 0.5 mg.
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Post by liane on Apr 20, 2016 16:30:59 GMT -5
I can tell you that a lot of asthmatics I know (and treating doctors) are aware that rescue inhalers these days just don't cut it. And clearly, if asthma were managed well for everyone (and this isn't always pilot error!) - there wouldn't be so many deaths. For those in the medical arena - think the TS formulation of epi would effectively open up those airways faster than primatene? That was fast, but it was like inhaling chlorine sometimes .... To the 1st point - you are so right. One of my med school classmates (and a good friend) died in his 3rd year of med school due to an asthma attack. Young, intelligent, and a really great guy - it was quite sobering. As to the 2nd point, I do think it would be every bit as fast as Primatene - and without any taste or odor.
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Post by peppy on Apr 20, 2016 16:36:31 GMT -5
Two more things and I'll call it a day for Epi. 1. How's this sound for Epi? 4U /8U - Asthma attacks 12U - Anaphylaxis (Pre-filled of course, but you get the idea. Nobody wants to be fumbling with cartridges when unable to breathe well.) 2. Now, Albuterol treats bronchospasm, too, such as caused by asthma and COPD. Epi can raise blood glucose levels. Somehow, these facts seem important to me... MNKD actually studied Albuterol if you look hard at their site. Contraindications are not what they seem. You had better warm up your tin foil hat if you ask me, and giddy up! I especially liked it when Hakan mentioned Nicotine Technosphere. That was the trifecta. Just that the dosing would be something more like 0.1, 0.3, and 0.5 mg. quote: Now, Albuterol treats bronchospasm, too, such as caused by asthma and COPD reply: A person I know with COPD told me, "when I use albuterol, I feel like I am drowning." That is an interesting take. Think about it, as you connect the normal saline to the air supply for the mist. Nebulizer.
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