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Post by Deleted on Aug 3, 2016 20:56:34 GMT -5
I have also thought that if MannKind were to make a Technosphere-Epinephrine that they should make, in addition to prefilled inhaler, a blister package similar to Afrezza, yet also able to be opened up and poured directly in the mouth or in a cup of water or a drink. You just jumped the shark. •Sublingual epinephrine administration in humans A preliminary study K.J. Simons, X. Gu, F.E.R. Simons Pediatric Allergy, University of Manitoba, Winnipeg, MB, Canada — “Ten men (mean ± SEM age 23 ± 2 yr, weight 70 ± 2 kg) completed the study. No serious adverse effects were observed. The mean ± SEM area under the plasma concentration time curve (AUC) values after placebo, 0.3 mg epinephrine SC, and 2.4 mg epinephrine sublingually were: 69.7 ± 6.9, 269.7 ± 54.4, and 136.7 ± 18.5 nMol/min, respectively. The AUCsublingual/AUCSC ranged from 14 to 154%, with a mean ± SEM of 66.6 ± 13.1%.”www.jacionline.org/article/S0091-6749(04)00410-5/abstract?showall=true=
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Post by Deleted on Aug 3, 2016 20:56:52 GMT -5
What? Do u think it's alkaseltzer? To be poured directly or in a cup of water to drink.. Please... Hakan would be interested to talk to you Epi is put down an ETT all the time. If I were deep in the woods and a friend was about to code, yeah, I'd pour an Epi powder down his throat. Edited to say, before someone corrects me—I already know it gets broken down in the stomach and doesn't work. There has never been an Epi than can be taken that way, but how do you know that problem can't be fixed? Please go back and look what Mnkd technology is based on and how rapid onset is crucial in such situations. You should probably ask why an insulin pill isn't available yet after all these years? Did you call Hakan yet?
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Post by Deleted on Aug 3, 2016 21:03:57 GMT -5
Epi is put down an ETT all the time. If I were deep in the woods and a friend was about to code, yeah, I'd pour an Epi powder down his throat. Edited to say, before someone corrects me—I already know it gets broken down in the stomach and doesn't work. There has never been an Epi than can be taken that way, but how do you know that problem can't be fixed? Please go back and look what Mnkd technology is based on and how rapid onset is crucial in such situations. You should probably ask why an insulin pill isn't available yet after all these years? Did you call Hakan yet? •ORAMED REPORTS ADDITIONAL PHASE IIB ORAL INSULIN STUDY DATA DEMONSTRATING SIGNIFICANT LOWERING OF GLUCOSE LEVELS VS PLACEBO www.oramed.com/oramed-reports-additional-phase-iib-oral-insulin-study-data-demonstrating-significant-lowering-of-glucose-levels-vs-placebo/Also, •Sublingual epinephrine administration in humans A preliminary study K.J. Simons, X. Gu, F.E.R. Simons Pediatric Allergy, University of Manitoba, Winnipeg, MB, Canada — “Ten men (mean ± SEM age 23 ± 2 yr, weight 70 ± 2 kg) completed the study. No serious adverse effects were observed. The mean ± SEM area under the plasma concentration time curve (AUC) values after placebo, 0.3 mg epinephrine SC, and 2.4 mg epinephrine sublingually were: 69.7 ± 6.9, 269.7 ± 54.4, and 136.7 ± 18.5 nMol/min, respectively. The AUCsublingual/AUCSC ranged from 14 to 154%, with a mean ± SEM of 66.6 ± 13.1%.”www.jacionline.org/article/S0091-6749(04)00410-5/abstract?showall=true=
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Post by Deleted on Aug 3, 2016 21:11:40 GMT -5
Epi is put down an ETT all the time. If I were deep in the woods and a friend was about to code, yeah, I'd pour an Epi powder down his throat. Edited to say, before someone corrects me—I already know it gets broken down in the stomach and doesn't work. There has never been an Epi than can be taken that way, but how do you know that problem can't be fixed? Please go back and look what Mnkd technology is based on and how rapid onset is crucial in such situations. You should probably ask why an insulin pill isn't available yet after all these years? Did you call Hakan yet? I think I said if someone were about to code. What makes you think sublingual Epi could not be useful in an emergency situation where other options are not possible? I was just throwing in a hypothetical scenario that would be beneficial if it could also be used that way. Where did I ever mention I wanted it to be the primary way of admin? I think you took what I said the wrong way.
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Post by dcassidy1618a on Aug 3, 2016 23:32:29 GMT -5
Please go back and look what Mnkd technology is based on and how rapid onset is crucial in such situations. You should probably ask why an insulin pill isn't available yet after all these years? Did you call Hakan yet? I think I said if someone were about to code. What makes you think sublingual Epi could not be useful in an emergency situation where other options are not possible? I was just throwing in a hypothetical scenario that would be beneficial if it could also be used that way. Where did I ever mention I wanted it to be the primary way of admin? I think you took what I said the wrong way. It looks like the whole point of that study is that sublingual administration could be a viable alternative to injections as a "primary way of admin," but epi is already avaiable as an oral formulation: dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6d5af590-59f6-4f34-95ff-226a2996f985I imagine that could be chewed and released sublinually as well.
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Post by Deleted on Aug 4, 2016 2:20:01 GMT -5
I think I said if someone were about to code. What makes you think sublingual Epi could not be useful in an emergency situation where other options are not possible? I was just throwing in a hypothetical scenario that would be beneficial if it could also be used that way. Where did I ever mention I wanted it to be the primary way of admin? I think you took what I said the wrong way. It looks like the whole point of that study is that sublingual administration could be a viable alternative to injections as a "primary way of admin," but epi is already avaiable as an oral formulation: dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6d5af590-59f6-4f34-95ff-226a2996f985I imagine that could be chewed and released sublinually as well. I have never heard of or seen that inhaler before. The website that owns it and sells it looks like a complete scam. Dr. Natural Healing...no comment.
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Post by lakon on Aug 4, 2016 11:06:10 GMT -5
I have never heard of or seen that inhaler before. The website that owns it and sells it looks like a complete scam. Dr. Natural Healing...no comment. I particularly liked the following from the link: "DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies." If ONLY...
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Post by lakon on Aug 4, 2016 11:17:40 GMT -5
Epi is put down an ETT all the time. If I were deep in the woods and a friend was about to code, yeah, I'd pour an Epi powder down his throat. Edited to say, before someone corrects me—I already know it gets broken down in the stomach and doesn't work. There has never been an Epi than can be taken that way, but how do you know that problem can't be fixed? Please go back and look what Mnkd technology is based on and how rapid onset is crucial in such situations. You should probably ask why an insulin pill isn't available yet after all these years? Did you call Hakan yet? Let's be fair to mango and NOT jump to conclusions YET. YES, inhaled pulmonary delivery with rapid onset is crucial in some situations, like being discussed for Anaphylaxis; however, mango points out some interesting options. Perhaps they might work rapidly enough, or perhaps not, but I think that the other "off label" applications would have less of an issue with the same suggestions. Surely, MNKD's strategy is to use the regulatory framework in the most advantageous way possible after the drubbing it gave them last time. Regarding insulin in a pill, I think that the true genius of Al Mann was realizing that TIME MATTERS when everyone assumed long ago that it does not. That said, for basal insulin, a pill would be ideal to put an end to all injections. I don't see ORMP doing it well. I do see how Technosphere could do it well. If only the FDA was not such a PITA. ...and for the record, an Epi pill would have applications, but the link provided was not meant as a pill. I think the intent was still inhalation.
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Post by mnholdem on Aug 4, 2016 11:32:31 GMT -5
I believe Lakon is correct... Technosphere+Epinephrine is coming. Would this be epic?? Not sure but timeline is getting close for possible news or update from mnkd. Thoughts? According to the company timetable, the Technology Assessment Phase should have just been completed where they reach the milestone of deciding their "Go/NoGo Decision" for continuing into the IND Enabling Phase.
Mike Catagna presented a slide (Page 13) at the last investors conference that MannKind is proceeding:
"Epinenephrine: Two formulations have been evaluated - Both meet performance criteria; PK profiling started"
If they maintain the planned timeline, the final decision to submit the IND will happen in 1Q17.
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Ironically, nobody's talking about the Trepostinil, which is slated for IND decision/submit this year:
Perhaps this one deserves its own thread...
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Post by liane on Aug 4, 2016 11:33:57 GMT -5
Epi degrades in the GI tract - not only do you lose the speed trying to give it orally, but also the efficacy.
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Post by esstan2001 on Aug 4, 2016 13:18:53 GMT -5
Please go back and look what Mnkd technology is based on and how rapid onset is crucial in such situations. You should probably ask why an insulin pill isn't available yet after all these years? Did you call Hakan yet? Let's be fair to mango and NOT jump to conclusions YET. YES, inhaled pulmonary delivery with rapid onset is crucial in some situations, like being discussed for Anaphylaxis; however, mango points out some interesting options. Perhaps they might work rapidly enough, or perhaps not, but I think that the other "off label" applications would have less of an issue with the same suggestions. Surely, MNKD's strategy is to use the regulatory framework in the most advantageous way possible after the drubbing it gave them last time. Regarding insulin in a pill, I think that the true genius of Al Mann was realizing that TIME MATTERS when everyone assumed long ago that it does not. That said, for basal insulin, a pill would be ideal to put an end to all injections. I don't see ORMP doing it well. I do see how Technosphere could do it well. If only the FDA was not such a PITA. ...and for the record, an Epi pill would have applications, but the link provided was not meant as a pill. I think the intent was still inhalation. Unigene, Tarsis(?) Emisphere, etc in collaborations with Novo, GSK, etc have all been working on an enteric coating for peptide delivery (Pth, calcitonin, insulin, GLP1, etc) through the gut. Successfully getting through there, and limiting dosing variability have kept the holy grail out of reach. Digestive trac delivery is fraught with variability. Someday, and it depends on the peptide / target treatment- but I do not think too soon.
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Post by audiomr on Aug 4, 2016 15:13:13 GMT -5
I just looked and there are studies on sublingual administration of Epinephrine that show postive results. So, yeah, I would guess that a MannKind version would produce effects if I put the powder under my tongue. Would depend on the chemistry required to release the epinephrine from Technosphere. Doesn't seem promising. Inhalation would be better for a conscious person, and injection would be better for an unconscious one.
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Post by Deleted on Aug 4, 2016 17:32:46 GMT -5
I just looked and there are studies on sublingual administration of Epinephrine that show postive results. So, yeah, I would guess that a MannKind version would produce effects if I put the powder under my tongue. Would depend on the chemistry required to release the epinephrine from Technosphere. Doesn't seem promising. Inhalation would be better for a conscious person, and injection would be better for an unconscious one. It appears that no one actually read what I said. I gave a very likely hypothetical scenario—hiking deep in the woods, no civilization within 60 miles. Your buddy is losing it and there are no options other than breaking the Technosphere-Epi and putting it under his tongue and literally holding his tongue down so it is absorbed sublingually. If you had 5-6 of these it could save his life. I gave you one study do you want another? Some of you have taken me just talking about something that would be a cool additional benefit and have twisted it into something completely different. Do ya'll not ever just talk about stuff without twisting what people say?
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Post by comnkd on Aug 4, 2016 20:54:08 GMT -5
My comment was related to MannKind being the company to develop what you outline. It does not fit their profile at this time.
On a personal note I'd welcome other delivery options for epinephrine. My son has a severe tree nut allergy and carrying around two bulky epi-pens is not ideal. That minor inconvenience is quickly dismissed given the alternative.
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Post by Deleted on Aug 4, 2016 22:17:38 GMT -5
My comment was related to MannKind being the company to develop what you outline. It does not fit their profile at this time. On a personal note I'd welcome other delivery options for epinephrine. My son has a severe tree nut allergy and carrying around two bulky epi-pens is not ideal. That minor inconvenience is quickly dismissed given the alternative. I'm sure I will be told to consult Hakan for this, but: •TechnoVax, Inc's VLP vaccine technology coupled with MannKind's Technosphere and inhaler technology could make a vaccine for this, IMO.
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