8 ms·

US FDA approves nasal spray alternative to EpiPen for allergic reactions

181 points by sweca 2y ago

jasinjames 2y ago
> 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. 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'm glad than an alternative is available for those fearful of them. (I didn'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't have administered for me!) [0]https://www.talktomira.com/post/how-much-does-an-epipen-cost https://www.talktomira.com/post/how-much-does-an-epipen-cost
- sweca 2y ago
  Not only is it cheaper, but you need to replace it much less as its shelf life is 30 months[0], compared to Epipens which are recommended every year of shelf life. [0]: https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-receives-fda-approval-neffyr-epinephrine https://ir.ars-pharma.com/news-releases/news-release-details...
- jawns 2y ago
  This is HUGE for kids. Nasal spray as a delivery method is a big step up from needles, the shelf life is much longer, it's less susceptible to high/low temperatures, and if the promotional pricing is accurate, it's cheaper than EpiPens and Auvi-Q (which talks you through the injection procedure). I wouldn't be surprised, though, if insurers continue to push generic epinephine injectors ($15-$30) merely from a cost perspective.
  - sweca 2y ago
    Hmm... Canada had something like Auvi-Q called Allerject but it was recalled due to mechanical malfunctions. https://www.cbc.ca/news/health/epipen-shortage-canada-1.3296678 https://www.cbc.ca/news/health/epipen-shortage-canada-1.3296...
    - FredFS456 2y ago
      It's available again, I have two that I bought this year.
- toomuchtodo 2y ago
  Slam dunk against EpiPen’s de facto monopoly.
  - NavinF 2y ago
    EpiPens have been generic for many years and most people don't buy the brand name EpiPen unless their insurance makes it free. Check CVS and goodrx
    - toomuchtodo 2y ago
      The ground truth I have from people in my circle is that it is still expensive and challenging to get them. Maybe that is not broadly the case, but based on that ground truth, I want cheap alternatives at scale.
      - NavinF 2y ago
        Sure, making things cheaper is always better. I'm just responding to the word "monopoly" which seems to get tossed around whenever anything is expensive without any thought on why it's expensive. The actual price of 2pk epipen is $109.99 and it lasts many years. As I mentioned in another comment, "Forty EpiPen and EpiPen Jr auto-injectors that had been expired for 1 to 50 months were tested. All 40 auto-injectors contained more than 80 percent of the labeled dose" https://www.foodallergy.org/fare-blog/expired-epinephrine-can-still-save-lives https://www.foodallergy.org/fare-blog/expired-epinephrine-ca... Unless some institution forces you to pay more (Eg schools and allergy shot providers checking expiry dates) the actual cost is ~$25/year if you don't have decent insurance and ~$0 if you do
        toomuchtodo 2y ago
        > Sure, making things cheaper is always better. I'm just responding to the word "monopoly" which seems to get tossed around whenever anything is expensive without any thought on why it's expensive. Paying hundreds of millions of dollars to settle antitrust claims sounds like a monopoly to me. https://www.biopharmadive.com/news/how-mylan-ended-up-with-an-epipen-monopoly/425050/ https://www.biopharmadive.com/news/how-mylan-ended-up-with-a... https://kffhealthnews.org/news/behind-the-epipen-monopoly-lobbying-muscle-flailing-competition-and-tragic-deaths/ https://kffhealthnews.org/news/behind-the-epipen-monopoly-lo... https://www.courthousenews.com/10th-circuit-asked-to-revive-epipen-monopoly-claims-for-jury-to-decide/ https://www.courthousenews.com/10th-circuit-asked-to-revive-... https://www.reuters.com/legal/litigation/pfizer-pay-50-mln-settle-drug-wholesalers-epipen-antitrust-claims-2023-10-11/ https://www.reuters.com/legal/litigation/pfizer-pay-50-mln-s... https://www.nbcnews.com/business/business-news/epipen-maker-pay-264-million-settle-lawsuit-rcna18082 https://www.nbcnews.com/business/business-news/epipen-maker-...
- deleted 2y ago
  [deleted]
- iends 2y ago
  The cheapest generic is $110 without insurance at CVS for two doses. https://www.cvs.com/content/epipen-alternative https://www.cvs.com/content/epipen-alternative (Sometimes you could need two doses in the event of an emergency, according to doctors.) I know this because I've been buying them for years without use (thankfully), on the off chance my son has a life threatening reaction to eggs.
  - jasinjames 2y ago
    Wow, this is incredible news! I had no idea this was available.
- floam 2y ago
  I knew someone that was… violently, ridiculously afraid of needles and to have them describe the time they had to stab a roommate with an Epi-Pen — after running outside and failing to find a Good Samaritan to do it — it was like hearing someone describe finding the courage to take a life or something, some kind of war story. He did finally do it, though. He also puked on the person. The guy had some kind of natural aversion combined with an apparently traumatic memory from childhood of being held down and poked multiple times (probably due to their resisting) by nurses.
  - BurningFrog 2y ago
    I'm convinced a lot of "antivaxxery" is simply redirected needle phobia.
    - odyssey7 2y ago
      Possibly. I wonder what keeps us from adopting needle-free vaccinations. It seems like the tech has been available but not fully developed for decades. We shouldn’t be dismissive about how sub-optimal it is that children are routinely held down and stabbed, against their protests, by authority figures. There’s nothing surprising about people growing up from this and not trusting medical experts.
      - recursivegirth 2y ago
        It depends, historically vaccines have been administered by injecting dead bacteria/organic matter that triggers your auto immune system to start generating the anti-bodies needed to fight whatever is being vaccinated against. Irrelevant to the topic, COVID vaccines were developed with new technology that uses synthetic materials. I am over simplifying a lot here, but the point is that sometimes you need to get that dead matter into the bloodstream to start the auto-immune processes.
        odyssey7 2y ago
        Historically, yes, but these days it seems more like a question of priorities. To your point, it does depend: there are needle-free options available for some vaccinations currently, though in many cases children are nonetheless forced to take the version that they beg to decline. The children have the least say in where the research funding goes, negotiating reimbursement contracts between payors and providers, planning pharma development pipelines… My opinion is that we’re failing them.
boarnoah 2y 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. The reasoning I'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. 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.... EDIT: Looking at the product page https://ars-pharma.com/product/ https://ars-pharma.com/product/ 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).
amluto 2y 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. 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.
- vlovich123 2y ago
  Don’t those students still need the epipen when they’re at home or otherwise out of school?
  - ryan-duve 2y ago
    Yes, but in addition to the one at home we also have to buy a separate one to sit in the nurse's office all year. Also, if the before/after school program doesn't have access to the nurse's office, we have yet another one that sits in their cabinet, too. They all come home at the end of the year, expire, repeat.
    - jessriedel 2y ago
      I don’t understand what the plausible alternative policy is. Each kid needs a personal one for when they are at home. They presumably should bring it with them to school for quick action and also for if they have an episode while commuting. The school could decline to carry them to save a bit of money each year, but it seems unwise to rely on (1) kids never forgetting their medication and (2) an adult always knowing where to find the child’s medication if they are unresponsive. So shouldn’t the school have a few?
      - ec109685 2y ago
        Every school should have a supply, period. Also makes sense for kids to carry.
modeless 2y ago
I don't care about the needleless part. The autoinjectors are easy to use and you never see the needle. This is the real win: > 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] 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's hot outside, you can't leave it in your car or even in a bag you're carrying. You'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. [1] https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-receives-fda-approval-neffyr-epinephrine https://ir.ars-pharma.com/news-releases/news-release-details...
- NavinF 2y ago
  As a practical matter epi-pens work just fine outside spec. Heat just speeds up the degradation. Also see https://www.foodallergy.org/fare-blog/expired-epinephrine-can-still-save-lives https://www.foodallergy.org/fare-blog/expired-epinephrine-ca... > Forty EpiPen and EpiPen Jr auto-injectors that had been expired for 1 to 50 months were tested. All 40 auto-injectors contained more than 80 percent of the labeled dose
  - modeless 2y ago
    Probably true but needs proof. They need to test and re-certify the existing devices for higher and lower temperatures, but they had no incentive to do so before there was competition. Hopefully this will be the swift kick in the butt they need.
    - labster 2y ago
      Why would they retest and recertify so they can sell half the product they used to sell? What company is crazy enough to lose that much money?
AbstractH24 2y ago
My first question is what took so long? 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 & it’s pretty miserable. Amazing the amount of power the teeth/jaw can have) and let’s just say the butthole option is unappealing. My second question is should I invest in the company? 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/perpetuates.) Their stock has tanked since going public for reasons I’ve yet to find time to research.
- BurningFrog 2y ago
  > My first question is what took so long? My bet is that FDA took 5 years longer than reasonable to clear it.
  - icegreentea2 2y ago
    FDA granted fast track in 2019 - fast track designation basically lets the company communicate with the FDA more frequently and with higher priority than otherwise, while granting a variety of administrative speed ups to the process. The initial submission for approval was in October 2022. The FDA replied in September 2023 asking for two specific additional pieces of information. The company submitted the new information in April 2024. * https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-announces-fda-acceptance-nda-neffyr https://ir.ars-pharma.com/news-releases/news-release-details... * https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-submits-response-fda-complete-response https://ir.ars-pharma.com/news-releases/news-release-details... A non-snarky answer for "what took so long", is that nasal dosing is challenging, especially since too much drug can cause adverse responses as well. ARS itself seems to have been founded in 2015. 7 years from company founding to submission (and 4 years to being granted fast track) is maybe... a little slow? But at the same time, how quickly do you expect a novel delivery mechanism for a life saving drug with an existing, effective and widespread alternative to go? * https://www.sec.gov/Archives/edgar/data/1671858/000119312523130585/d505184dars.pdf https://www.sec.gov/Archives/edgar/data/1671858/000119312523...
floam 2y 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. I think they need some differentiating shape or like assigned danger colors for the most common emergency nasal applications.
- floam 2y ago
  Although for an OD, if you had nothing but an Epi-Pen nearby, it would be better than nothing. It could possibly help. We know stimulants help with respiratory depression. I don’t think an opiate antagonist could be helpful for anaphylaxis though.
_heimdall 2y ago
An important note missing in the article, the FDA approved this with the Fast Track designation [1]. I'm still looking for the safety and efficacy study done. I also haven'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? [1] https://www.fda.gov/news-events/press-announcements/fda-approves-first-nasal-spray-treatment-anaphylaxis https://www.fda.gov/news-events/press-announcements/fda-appr...
nhyun 2y ago
What about Primatene Mist inhaler? Available OTC, 0.125 mg of epinephrine per spray.
- sweca 2y ago
  Haven't heard of that one. But neffy uses 3 mg of epinephrine.
  - modeless 2y ago
    Whoa, I had no idea epinephrine was OTC! 0.125mg per spray but 160 sprays per bottle. I guess 25 sprays would be a bit much all at once...
    - AbstractH24 2y ago
      That also assumes you need the same dosage via the lungs as via the nose
Shav779 2y ago
Wouldn'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're dealing with a non-breathing patient.
- sweca 2y ago
  The patient does not need to be actively inhaling, even though it's recommended. There's enough pressure that the nasal spray will spring up into the nasal mucosa to be absorbed into the blood.
TSP00N3 2y 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: https://pubmed.ncbi.nlm.nih.gov/17472409/ https://pubmed.ncbi.nlm.nih.gov/17472409/
- NavinF 2y ago
  The last 2 sentences of the abstract you linked: > Of these, only two studies in rats were able to provide results that can be seen as an indication for direct transport from the nose to the CNS. No pharmacokinetic evidence could be found to support a claim that nasal administration of drugs in humans will result in an enhanced delivery to their target sites in the brain compared with intravenous administration of the same drug under similar dosage conditions

181 points by sweca 2y ago

> 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. 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'm glad than an alternative is available for those fearful of them. (I didn'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't have administered for me!) [0]https://www.talktomira.com/post/how-much-does-an-epipen-cost https://www.talktomira.com/post/how-much-does-an-epipen-cost

sweca 2y ago
Not only is it cheaper, but you need to replace it much less as its shelf life is 30 months[0], compared to Epipens which are recommended every year of shelf life. [0]: https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-receives-fda-approval-neffyr-epinephrine https://ir.ars-pharma.com/news-releases/news-release-details...
jawns 2y ago
This is HUGE for kids. Nasal spray as a delivery method is a big step up from needles, the shelf life is much longer, it's less susceptible to high/low temperatures, and if the promotional pricing is accurate, it's cheaper than EpiPens and Auvi-Q (which talks you through the injection procedure). I wouldn't be surprised, though, if insurers continue to push generic epinephine injectors ($15-$30) merely from a cost perspective.
- sweca 2y ago
  Hmm... Canada had something like Auvi-Q called Allerject but it was recalled due to mechanical malfunctions. https://www.cbc.ca/news/health/epipen-shortage-canada-1.3296678 https://www.cbc.ca/news/health/epipen-shortage-canada-1.3296...
  - FredFS456 2y ago
    It's available again, I have two that I bought this year.
toomuchtodo 2y ago
Slam dunk against EpiPen’s de facto monopoly.
- NavinF 2y ago
  EpiPens have been generic for many years and most people don't buy the brand name EpiPen unless their insurance makes it free. Check CVS and goodrx
  - toomuchtodo 2y ago
    The ground truth I have from people in my circle is that it is still expensive and challenging to get them. Maybe that is not broadly the case, but based on that ground truth, I want cheap alternatives at scale.
    - NavinF 2y ago
      Sure, making things cheaper is always better. I'm just responding to the word "monopoly" which seems to get tossed around whenever anything is expensive without any thought on why it's expensive. The actual price of 2pk epipen is $109.99 and it lasts many years. As I mentioned in another comment, "Forty EpiPen and EpiPen Jr auto-injectors that had been expired for 1 to 50 months were tested. All 40 auto-injectors contained more than 80 percent of the labeled dose" https://www.foodallergy.org/fare-blog/expired-epinephrine-can-still-save-lives https://www.foodallergy.org/fare-blog/expired-epinephrine-ca... Unless some institution forces you to pay more (Eg schools and allergy shot providers checking expiry dates) the actual cost is ~$25/year if you don't have decent insurance and ~$0 if you do
      - toomuchtodo 2y ago
        > Sure, making things cheaper is always better. I'm just responding to the word "monopoly" which seems to get tossed around whenever anything is expensive without any thought on why it's expensive. Paying hundreds of millions of dollars to settle antitrust claims sounds like a monopoly to me. https://www.biopharmadive.com/news/how-mylan-ended-up-with-an-epipen-monopoly/425050/ https://www.biopharmadive.com/news/how-mylan-ended-up-with-a... https://kffhealthnews.org/news/behind-the-epipen-monopoly-lobbying-muscle-flailing-competition-and-tragic-deaths/ https://kffhealthnews.org/news/behind-the-epipen-monopoly-lo... https://www.courthousenews.com/10th-circuit-asked-to-revive-epipen-monopoly-claims-for-jury-to-decide/ https://www.courthousenews.com/10th-circuit-asked-to-revive-... https://www.reuters.com/legal/litigation/pfizer-pay-50-mln-settle-drug-wholesalers-epipen-antitrust-claims-2023-10-11/ https://www.reuters.com/legal/litigation/pfizer-pay-50-mln-s... https://www.nbcnews.com/business/business-news/epipen-maker-pay-264-million-settle-lawsuit-rcna18082 https://www.nbcnews.com/business/business-news/epipen-maker-...
deleted 2y ago
[deleted]
iends 2y ago
The cheapest generic is $110 without insurance at CVS for two doses. https://www.cvs.com/content/epipen-alternative https://www.cvs.com/content/epipen-alternative (Sometimes you could need two doses in the event of an emergency, according to doctors.) I know this because I've been buying them for years without use (thankfully), on the off chance my son has a life threatening reaction to eggs.
- jasinjames 2y ago
  Wow, this is incredible news! I had no idea this was available.
floam 2y ago
I knew someone that was… violently, ridiculously afraid of needles and to have them describe the time they had to stab a roommate with an Epi-Pen — after running outside and failing to find a Good Samaritan to do it — it was like hearing someone describe finding the courage to take a life or something, some kind of war story. He did finally do it, though. He also puked on the person. The guy had some kind of natural aversion combined with an apparently traumatic memory from childhood of being held down and poked multiple times (probably due to their resisting) by nurses.
- BurningFrog 2y ago
  I'm convinced a lot of "antivaxxery" is simply redirected needle phobia.
  - odyssey7 2y ago
    Possibly. I wonder what keeps us from adopting needle-free vaccinations. It seems like the tech has been available but not fully developed for decades. We shouldn’t be dismissive about how sub-optimal it is that children are routinely held down and stabbed, against their protests, by authority figures. There’s nothing surprising about people growing up from this and not trusting medical experts.
    - recursivegirth 2y ago
      It depends, historically vaccines have been administered by injecting dead bacteria/organic matter that triggers your auto immune system to start generating the anti-bodies needed to fight whatever is being vaccinated against. Irrelevant to the topic, COVID vaccines were developed with new technology that uses synthetic materials. I am over simplifying a lot here, but the point is that sometimes you need to get that dead matter into the bloodstream to start the auto-immune processes.
      - odyssey7 2y ago
        Historically, yes, but these days it seems more like a question of priorities. To your point, it does depend: there are needle-free options available for some vaccinations currently, though in many cases children are nonetheless forced to take the version that they beg to decline. The children have the least say in where the research funding goes, negotiating reimbursement contracts between payors and providers, planning pharma development pipelines… My opinion is that we’re failing them.

boarnoah 2y 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. The reasoning I'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. 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.... EDIT: Looking at the product page https://ars-pharma.com/product/ https://ars-pharma.com/product/ 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).

amluto 2y 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. 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.

vlovich123 2y ago
Don’t those students still need the epipen when they’re at home or otherwise out of school?
- ryan-duve 2y ago
  Yes, but in addition to the one at home we also have to buy a separate one to sit in the nurse's office all year. Also, if the before/after school program doesn't have access to the nurse's office, we have yet another one that sits in their cabinet, too. They all come home at the end of the year, expire, repeat.
  - jessriedel 2y ago
    I don’t understand what the plausible alternative policy is. Each kid needs a personal one for when they are at home. They presumably should bring it with them to school for quick action and also for if they have an episode while commuting. The school could decline to carry them to save a bit of money each year, but it seems unwise to rely on (1) kids never forgetting their medication and (2) an adult always knowing where to find the child’s medication if they are unresponsive. So shouldn’t the school have a few?
    - ec109685 2y ago
      Every school should have a supply, period. Also makes sense for kids to carry.

modeless 2y ago

I don't care about the needleless part. The autoinjectors are easy to use and you never see the needle. This is the real win: > 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] 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's hot outside, you can't leave it in your car or even in a bag you're carrying. You'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. [1] https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-receives-fda-approval-neffyr-epinephrine https://ir.ars-pharma.com/news-releases/news-release-details...

NavinF 2y ago
As a practical matter epi-pens work just fine outside spec. Heat just speeds up the degradation. Also see https://www.foodallergy.org/fare-blog/expired-epinephrine-can-still-save-lives https://www.foodallergy.org/fare-blog/expired-epinephrine-ca... > Forty EpiPen and EpiPen Jr auto-injectors that had been expired for 1 to 50 months were tested. All 40 auto-injectors contained more than 80 percent of the labeled dose
- modeless 2y ago
  Probably true but needs proof. They need to test and re-certify the existing devices for higher and lower temperatures, but they had no incentive to do so before there was competition. Hopefully this will be the swift kick in the butt they need.
  - labster 2y ago
    Why would they retest and recertify so they can sell half the product they used to sell? What company is crazy enough to lose that much money?

AbstractH24 2y ago

My first question is what took so long? 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 & it’s pretty miserable. Amazing the amount of power the teeth/jaw can have) and let’s just say the butthole option is unappealing. My second question is should I invest in the company? 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/perpetuates.) Their stock has tanked since going public for reasons I’ve yet to find time to research.

BurningFrog 2y ago
> My first question is what took so long? My bet is that FDA took 5 years longer than reasonable to clear it.
- icegreentea2 2y ago
  FDA granted fast track in 2019 - fast track designation basically lets the company communicate with the FDA more frequently and with higher priority than otherwise, while granting a variety of administrative speed ups to the process. The initial submission for approval was in October 2022. The FDA replied in September 2023 asking for two specific additional pieces of information. The company submitted the new information in April 2024. * https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-announces-fda-acceptance-nda-neffyr https://ir.ars-pharma.com/news-releases/news-release-details... * https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-submits-response-fda-complete-response https://ir.ars-pharma.com/news-releases/news-release-details... A non-snarky answer for "what took so long", is that nasal dosing is challenging, especially since too much drug can cause adverse responses as well. ARS itself seems to have been founded in 2015. 7 years from company founding to submission (and 4 years to being granted fast track) is maybe... a little slow? But at the same time, how quickly do you expect a novel delivery mechanism for a life saving drug with an existing, effective and widespread alternative to go? * https://www.sec.gov/Archives/edgar/data/1671858/000119312523130585/d505184dars.pdf https://www.sec.gov/Archives/edgar/data/1671858/000119312523...

floam 2y 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. I think they need some differentiating shape or like assigned danger colors for the most common emergency nasal applications.

floam 2y ago
Although for an OD, if you had nothing but an Epi-Pen nearby, it would be better than nothing. It could possibly help. We know stimulants help with respiratory depression. I don’t think an opiate antagonist could be helpful for anaphylaxis though.

_heimdall 2y ago

An important note missing in the article, the FDA approved this with the Fast Track designation [1]. I'm still looking for the safety and efficacy study done. I also haven'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? [1] https://www.fda.gov/news-events/press-announcements/fda-approves-first-nasal-spray-treatment-anaphylaxis https://www.fda.gov/news-events/press-announcements/fda-appr...

nhyun 2y ago

What about Primatene Mist inhaler? Available OTC, 0.125 mg of epinephrine per spray.

sweca 2y ago
Haven't heard of that one. But neffy uses 3 mg of epinephrine.
- modeless 2y ago
  Whoa, I had no idea epinephrine was OTC! 0.125mg per spray but 160 sprays per bottle. I guess 25 sprays would be a bit much all at once...
  - AbstractH24 2y ago
    That also assumes you need the same dosage via the lungs as via the nose

Shav779 2y ago

Wouldn'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're dealing with a non-breathing patient.

sweca 2y ago
The patient does not need to be actively inhaling, even though it's recommended. There's enough pressure that the nasal spray will spring up into the nasal mucosa to be absorbed into the blood.

TSP00N3 2y 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: https://pubmed.ncbi.nlm.nih.gov/17472409/ https://pubmed.ncbi.nlm.nih.gov/17472409/

NavinF 2y ago
The last 2 sentences of the abstract you linked: > Of these, only two studies in rats were able to provide results that can be seen as an indication for direct transport from the nose to the CNS. No pharmacokinetic evidence could be found to support a claim that nasal administration of drugs in humans will result in an enhanced delivery to their target sites in the brain compared with intravenous administration of the same drug under similar dosage conditions