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US FDA approves nasal spray alternative to EpiPen for allergic reactions

181 pointsby sweca9 months ago

10 comments

modeless9 months ago
I don&#x27;t care about the needleless part. The autoinjectors are easy to use and you never see the needle. <i>This</i> is the real win:<p>&gt; The shelf life of neffy is 30 months and allows for temperature exposure up to 122°F (50°C), making it a potentially effective treatment if left in a car or outside for a length of time. If accidentally frozen, neffy can be thawed and administered. [1]<p>The need to keep Epi-Pens below 77 degrees F (86F for short periods) is extremely constraining for something that you are supposed to carry with you at all times. Even keeping it in a jeans pocket next to your skin may not be acceptable, technically. If it&#x27;s hot outside, you can&#x27;t leave it in your car or even in a bag you&#x27;re carrying. You&#x27;re supposed to carry a thermos bottle with you the whole day every day or something? Obviously very few people do that. This is going to be far better for that reason alone. And double the shelf life is very welcome too.<p>[1] <a href="https:&#x2F;&#x2F;ir.ars-pharma.com&#x2F;news-releases&#x2F;news-release-details&#x2F;ars-pharmaceuticals-receives-fda-approval-neffyr-epinephrine" rel="nofollow">https:&#x2F;&#x2F;ir.ars-pharma.com&#x2F;news-releases&#x2F;news-release-details...</a>
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jasinjames9 months ago
&gt; ARS Pharma will offer neffy at a price of $199 for two doses via digital pharmacy sites like BlinkRx and GoodRx for eligible patients whose insurance plans do not cover neffy. Some commercially insured patients can access the treatment at $25 for each filled prescription of two single-use neffy devices through a co-pay savings program.<p>This is considerably lower than the non-insured cost of an Epi-Pen or generic equivalent[0]. Hopefully this spurs some competition and makes the whole market more affordable. I needed to use an Epi-pen in college, and though I never took issue with needles I&#x27;m glad than an alternative is available for those fearful of them.<p>(I didn&#x27;t feel it. I was about to pass out. But I remember looking up from the floor while administering and seeing my RA terrified. He was so scared of needles that if I had lost consciousness, he wouldn&#x27;t have administered for me!)<p>[0]<a href="https:&#x2F;&#x2F;www.talktomira.com&#x2F;post&#x2F;how-much-does-an-epipen-cost" rel="nofollow">https:&#x2F;&#x2F;www.talktomira.com&#x2F;post&#x2F;how-much-does-an-epipen-cost</a>
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boarnoah9 months ago
In first aid training one is told to be very careful regarding how you deploy an Epipen, since an accidental jab on an appendage (usually the thumb) is very bad news.<p>The reasoning I&#x27;ve heard is since Epinephrine constricts blood supply to the region and you can kill the tissue in an area with small blood vessels like your fingers.<p>Anyone aware of what the risks of a spray would be in similar contexts? I imagine stabbing a finger is not a risk here, but what about the spray getting anywhere other than the nose like in eyes etc....<p>EDIT: Looking at the product page <a href="https:&#x2F;&#x2F;ars-pharma.com&#x2F;product&#x2F;" rel="nofollow">https:&#x2F;&#x2F;ars-pharma.com&#x2F;product&#x2F;</a> it looks a lot like a Naloxone nasal spray so, I suppose its easier to position it in nose (not an inhaler like thing as I was imagining).
AbstractH249 months ago
My first question is what took so long?<p>For epilepsy, rescue meds to prevent one seizure from triggering another have started coming in the form of nasal spray for at least 5 years already. Before that, outside of hospitals you either had to put a pill under someone’s tongue or cream in their butthole. You couldn’t put it under their tounge during a seizure out of risk they’d bite your finger (I’m currently recovering from a tongue bite I got after having a seizure while alone 8 days ago &amp; it’s pretty miserable. Amazing the amount of power the teeth&#x2F;jaw can have) and let’s just say the butthole option is unappealing.<p>My second question is should I invest in the company?<p>This seems like it has the potential to sell a ton. And if margins are anything like the nasal rescue med for epilepsy they are massive. The epilepsy nasal sprays are about $300 each without insurance, the same med in pill form is about 10 cents. (Yes, I’ve struggled a lot over the years with the level of privilege and inequality that having access to them reflects&#x2F;perpetuates.) Their stock has tanked since going public for reasons I’ve yet to find time to research.
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amluto9 months ago
I would love to see the way that ownership of these devices is managed. I find it rather obnoxious that every child who may need epinephrine is supposed to keep their own device at school — this means that each student needs an extra device, and most of them just sit around until expiration.<p>If the school could buy and store a reasonable number (funded, on a fractional basis, by the insurers of the students who need them) and use them as needed (with replacement paid for by the recipient’s insurance), the students’ lives would be simpler and a lot less money would be spent.
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_heimdall9 months ago
An important note missing in the article, the FDA approved this with the Fast Track designation [1].<p>I&#x27;m still looking for the safety and efficacy study done. I also haven&#x27;t yet found the justification for fast tracking this. An alternative to an epipen injection seems reasonable, but why rush it through when we already have the epipen?<p>[1] <a href="https:&#x2F;&#x2F;www.fda.gov&#x2F;news-events&#x2F;press-announcements&#x2F;fda-approves-first-nasal-spray-treatment-anaphylaxis" rel="nofollow">https:&#x2F;&#x2F;www.fda.gov&#x2F;news-events&#x2F;press-announcements&#x2F;fda-appr...</a>
floam9 months ago
Looks just like Narcan. I think some design work needs to go into making sure these are never confused for each other. The result would be likely deadly.<p>I think they need some differentiating shape or like assigned danger colors for the most common emergency nasal applications.
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TSP00N39 months ago
Any concern here of the nasal spray crossing the blood brain barrier in a way that the EpiPen doesn’t? I found a study from 2007 with semi-mixed results: <a href="https:&#x2F;&#x2F;pubmed.ncbi.nlm.nih.gov&#x2F;17472409&#x2F;" rel="nofollow">https:&#x2F;&#x2F;pubmed.ncbi.nlm.nih.gov&#x2F;17472409&#x2F;</a>
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Shav7799 months ago
Wouldn&#x27;t a needle be better as it allows it to be administered to a non-breathing patient vs a nasal spray which presumably only works when the patient is breathing? I have to assume that with anaphylaxis it is a reasonable likelihood that you&#x27;re dealing with a non-breathing patient.
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nhyun9 months ago
What about Primatene Mist inhaler? Available OTC, 0.125 mg of epinephrine per spray.
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