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Post by cm5 on Apr 20, 2016 17:20:48 GMT -5
Hmm, speaking here as someone with anaphylaxis, I ask the following: - How many naysayers re: epinephrine in Technosphere have ever jabbed themselves in the thigh with an EpiPen, while suffering at the same time with the sense of impending doom, being distressed that the injector might not work right, fearful that one might drop the injector, and hating how much the forceful jab of the needle is going to hurt, and thinking "Do I really need to do it this time?"
- In other words, until you have lived anaphylaxis and tried to find your EpiPen, and realized you did not bring it that day because it was too big for your jacket pocket, or it was in your briefcase in another office or the conference room, or it's expired, and suddenly you life is fading away----
- In other words, this is a enormous issue of possible death, if not a miserable experience waiting for EMT's, or a long night in an ER when a pocket sized Technosphere filled with epinephrine could have stopped progression to circulatory collapse, obstruction of airway, and consequent intubation and IV Solution-Medrol.
- There is a enormous unmet need for convenient self medication with epinephrine when one is aware that anaphylaxis is a possibility or probable.
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Post by prosper on Apr 20, 2016 18:21:06 GMT -5
It seems to me that since T is faster acting than injected insulin then T carrying E would also be faster acting and therefore more effective.
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Post by hankscorpio7 on Apr 20, 2016 22:58:55 GMT -5
Really pushing this epi lakon, do u work for MNKD?
Has Civitas Therapeutics been discussed here? You know, the one applying for a patent for an inhalable, epinephrine dry powder? It wasn't as effective as the epi pen... Even if TS epi is full steam ahead, they are at least a year behind Civitas. Civitas is being acquired so that may delay them. Funny, being acquired by company recruiting for an inhalable migraine med. Maybe FDA will allow NDA or whatever without Phase III or IVs, but with that much epi immediately hitting the heart- I imagine they would want certainty.
I'm sure AMPH would jump at a new primatene, but they are hurting for cash.
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Post by BlueCat on Apr 20, 2016 23:11:46 GMT -5
Hmm, speaking here as someone with anaphylaxis, I ask the following: - How many naysayers re: epinephrine in Technosphere have ever jabbed themselves in the thigh with an EpiPen, while suffering at the same time with the sense of impending doom, being distressed that the injector might not work right, fearful that one might drop the injector, and hating how much the forceful jab of the needle is going to hurt, and thinking "Do I really need to do it this time?"
- In other words, until you have lived anaphylaxis and tried to find your EpiPen, and realized you did not bring it that day because it was too big for your jacket pocket, or it was in your briefcase in another office or the conference room, or it's expired, and suddenly you life is fading away----
- In other words, this is a enormous issue of possible death, if not a miserable experience waiting for EMT's, or a long night in an ER when a pocket sized Technosphere filled with epinephrine could have stopped progression to circulatory collapse, obstruction of airway, and consequent intubation and IV Solution-Medrol.
- There is a enormous unmet need for convenient self medication with epinephrine when one is aware that anaphylaxis is a possibility or probable.
You really nailed it: "Do I really need to do it this time?" Not unlike making a decision to call an ambulance, either. It would be soo much easier with a preloaded cricket. The worst consequence you'd have to consider at that point might be a lot of jitters/shakes and a difficult night sleep. Not to mention - can't tell you how many times I left the house without the thing, with that nagging thought in the back of my mind .... "But what if ...." Or having to tell people at work ... "O btw, should it ever be necessary, I generally keep ...." PS> from earlier comment by other poster - it wasn't so much taste as the occasional burn of Primatene ..... you know, like bleach in the steam and accidentally inhaling ....
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Post by Deleted on Apr 20, 2016 23:17:13 GMT -5
Really pushing this epi lakon, do u work for MNKD? Has Civitas Therapeutics been discussed here? You know, the one applying for a patent for an inhalable, epinephrine dry powder? It wasn't as effective as the epi pen... Even if TS epi is full steam ahead, they are at least a year behind Civitas. Civitas is being acquired so that may delay them. Funny, being acquired by company recruiting for an inhalable migraine med. Maybe FDA will allow NDA or whatever without Phase III or IVs, but with that much epi immediately hitting the heart- I imagine they would want certainty. I'm sure AMPH would jump at a new primatene, but they are hurting for cash. is it plumiaz? if so its nasal. For migraines , its certainly dry powder CVT-427
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Post by jerrys on Apr 20, 2016 23:52:02 GMT -5
Judging from some of the responses, I think many missed the point of my original post:
"Before they pursue the idea, they really should survey docs to see whether any would presecribe it. Given the nature of anaphylaxis:
nonutsmomsgroup.weebly.com/blog/remembering-those-we-have-lost-to-food-allergies
...I seriously doubt any would risk prescribing a drug that depended on adequate inhalation for it to work."
My main point was to determine whether MNKD has actually surveyed docs to see whether they would ever prescribe an inhaled substance to treat anaphylaxis. My opinion is that docs wouldn't prescribe inhaled epi for the reasons listed on that website I linked. If a doc prescribes something for anaphylaxis, he is, in effect, signing a contract saying that if the patient uses this medicine as instructed, it will treat the patient's illness. That contract means the doc takes responsibility for the events subsequent to when the patient chooses to use it. Anaphylaxis, by definition:
"Anaphylaxis is a type of allergic reaction, in which the immune system responds to otherwise harmless substances from the environment. Unlike other allergic reactions, however, anaphylaxis can kill. Reaction may begin within minutes or even seconds of exposure, and rapidly progress to cause airway constriction, skin and intestinal irritation, and altered heart rhythms. In severe cases, it can result in complete airway obstruction, shock, and death."
A malpractice lawyer would skin alive any doctor who prescribed an inhaled drug to treat a condition where airway constriction and obstruction are part of the definition of the disease -- simple as that. I really don't believe any doc would want to put themselves in that position. It simply seems the first, most rational thing to do is determine how many docs would ever prescribe it.
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Post by anderson on Apr 21, 2016 1:08:25 GMT -5
Judging from some of the responses, I think many missed the point of my original post: "Before they pursue the idea, they really should survey docs to see whether any would presecribe it. Given the nature of anaphylaxis: nonutsmomsgroup.weebly.com/blog/remembering-those-we-have-lost-to-food-allergies ...I seriously doubt any would risk prescribing a drug that depended on adequate inhalation for it to work." My main point was to determine whether MNKD has actually surveyed docs to see whether they would ever prescribe an inhaled substance to treat anaphylaxis. My opinion is that docs wouldn't prescribe inhaled epi for the reasons listed on that website I linked. If a doc prescribes something for anaphylaxis, he is, in effect, signing a contract saying that if the patient uses this medicine as instructed, it will treat the patient's illness. That contract means the doc takes responsibility for the events subsequent to when the patient chooses to use it. Anaphylaxis, by definition: "Anaphylaxis is a type of allergic reaction, in which the immune system responds to otherwise harmless substances from the environment. Unlike other allergic reactions, however, anaphylaxis can kill. Reaction may begin within minutes or even seconds of exposure, and rapidly progress to cause airway constriction, skin and intestinal irritation, and altered heart rhythms. In severe cases, it can result in complete airway obstruction, shock, and death." A malpractice lawyer would skin alive any doctor who prescribed an inhaled drug to treat a condition where airway constriction and obstruction are part of the definition of the disease -- simple as that. I really don't believe any doc would want to put themselves in that position. It simply seems the first, most rational thing to do is determine how many docs would ever prescribe it. Maybe you dont get the point. They would prescribe both. This would replace take a benadryl or wait and see if you have a reaction. If you wait and see it might be too late. blog.onespotallergy.com/2014/06/tragic-loss-of-sacramento-teen-reveals-flaws-in-anaphylaxis-guidelines/comment-page-1/
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Post by babaoriley on Apr 21, 2016 1:18:12 GMT -5
Forget about Epi; small potatoes, but how's this for outside the box thinking. What if insulin could be administered with technosphere? So much faster and easier. They might even come up with a formulation of insulin that would work faster, get in quick, get out quick. Can you imagine how that would sell?
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Post by prosper on Apr 21, 2016 7:13:01 GMT -5
A close friend, who owns a pharmacy, replied when i sent him the Epi facts, that he sees huge potential for a Technosphere application to replace the Epi pens. He states that not only are the cost of the pens ridiculously expensive, but they also expire in a relatively short period of time. I have never completely understood how long A can remain viable in a non-refridgerated environment, but i do remember a lot of back and forth on the YMB years ago regarding T as a vaccine vehicle for primitive areas like sub-Sahara Africa/India, etc. I don't remember. It seems to me that T should be at least as long lived as the current pens as an Epi vehicle.
Comments?
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Post by Deleted on Apr 21, 2016 7:23:52 GMT -5
A close friend, who owns a pharmacy, replied when i sent him the Epi facts, that he sees huge potential for a Technosphere application to replace the Epi pens. He states that not only are the cost of the pens ridiculously expensive, but they also expire in a relatively short period of time. I have never completely understood how long A can remain viable in a non-refridgerated environment, but i do remember a lot of back and forth on the YMB years ago regarding T as a vaccine vehicle for primitive areas like sub-Sahara Africa/India, etc. I don't remember. It seems to me that T should be at least as long lived as the current pens as an Epi vehicle. Comments? Comments? You already have lots above. I think it's been discussed enough that we are out of substantial points
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Post by lakon on Apr 21, 2016 10:32:46 GMT -5
Really pushing this epi lakon, do u work for MNKD? Has Civitas Therapeutics been discussed here? You know, the one applying for a patent for an inhalable, epinephrine dry powder? It wasn't as effective as the epi pen... Even if TS epi is full steam ahead, they are at least a year behind Civitas. Civitas is being acquired so that may delay them. Funny, being acquired by company recruiting for an inhalable migraine med. Maybe FDA will allow NDA or whatever without Phase III or IVs, but with that much epi immediately hitting the heart- I imagine they would want certainty. I'm sure AMPH would jump at a new primatene, but they are hurting for cash. Not pushing at all, just open analysis and an opinion. Of course, NO, I do not work for MNKD. That would be unethical and too restrictive for me. MNKD is a very ethical and even morally sensitive company so I don't see them doing anything shady like pumping either, not that I was pumping. That's part of what makes them a great target for shorts like you. LOL. Seriously, good job about bringing up Civitas Therapeutics. I'm glad that you did. It gave me an idea for another thread. Anyway, your information seems outdated. Civitas came from the failed Eli Lilly experiment in inhaled insulin. Nice try. They had some trouble convincing the FDA that their follow-on work with an anti-epileptic was okay. Acorda is focusing on neurological disorders, and they bought Civitas for their Parkinson's drug. It does not look like they are continuing the Epi candidate. I see no mention of it. Of course, there is no point in rehashing old and discarded discussions, besides remembering that Civitas was acquired for $525 million, but did not have an FDA-approved drug. They had what appears to be an inferior knockoff of Technosphere that has failed repeatedly to produce any FDA-approved drugs. Opinions may vary, but Lilly dumped them so there's that... www.google.com/patents/US7947742www.acorda.com/products/pipelinewww.wsj.com/articles/acorda-to-buy-civitas-therapeutics-for-525-million-1411561640www.reuters.com/article/us-acorda-therapeutics-m-a-civitas-idUSKCN0HJ17Z20140924Actually, your knowledge of AMPH appears dated too. You might want to listen to their conference calls to get up to speed. They own Primatene, and they have a new version. The only reason that it is not back on the market has to do with the new formula requiring that end users shake before use. This change made the FDA worry about people following old usage habits. AMPH seems to be resolving the matter with the FDA for the safety of patients, and the new Primatene will be out soon, maybe next year. Yet, long-term, a Technosphere Epi may be better for AMPH, MNKD, and patients. As far as hurting for cash, not so much. AMPH is profitable and on an acquisition spree, as much as a small company can be. Still, they are adding to their vertical integration. They have all the makings of a great generic and specialty pharma down the road, especially in league with MNKD.
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Post by lakon on Apr 21, 2016 10:53:14 GMT -5
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Post by lakon on Apr 21, 2016 11:13:45 GMT -5
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Post by end2war on Apr 21, 2016 12:14:32 GMT -5
Personally, I find this discussion by CM5 to be completely convincing. There is a very big place for an inhaled Epinephrine. It will sell well and it should be brought to market with TS if possible, IMO.
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Post by mnkdfann on Apr 21, 2016 12:29:55 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. Is there any medical basis to support your opinion? Is it really safe or wise to take epinephrine just as a protective measure? Or to dose yourself 10 times more than necessary? I've no idea, but I have my doubts. I have to say if I am going to carry just one device, I would carry the pen to be safe. Because someone else can always inject me, or I can still inject myself, on those occasions an attack is causing breathing difficulties that would prevent inhaled epi from being used.
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