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.
> 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
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.
I have anaphylaxis and I highly disagree about the needle being insignificant. It can be and has been a huge cause of inaction due to fear of feeling and misplacing the needle, e.g. puncturing a vein. I think both can be true: the additional shelf life is fantastic, but so is the needle-free usage.
I also have anaphylaxis, use epipens and have never worried about hitting a vein. I don't think I've ever felt the needle when I've used my epipens. But I do think the needle worries other people who might have to administer it to me though and maybe makes them a bit more reluctant to do so.
Going to hospital afterwards (to be monitored for late phase reaction and receive high dose antihistamine and hydrocortisone) usually seems to involve putting a cannula in my hand for IV medication which is pretty well guaranteed to be much more unpleasant.
The needless part is the one I think of first. Our daughter is 10, and as soon as we bring up "here's an injector" to school personnel or friends parents when she's staying over, there's a frightened look in their eyes.
This will allow us to be much more relaxed, since the risk of anyone panicking when administering is lower, the risk of doing it wrong is significantly lower, and the stigmata is also lower compared to a needle.
The hard part being, front the patient POV we didn't know if it's in excess of precaution or something really critical.
There's a decent selection of thermo cases that are small enough to make it manageable, but it's definitely a complicating factor, especially for smaller kids.
In my country, injecting a drug via needle is a medical activity only the patient himself, doctor and the nurse instructed by doctor can perform by law.
For EpiPen, the regulation is slightly relaxed so the paramedics, parents/childcare workers/school teachers responsible for the child patient can also use it.
But when the EpiPen is needed, the patients often can't administer himself.
> 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!)
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.
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.
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.
Agree. I didn't even think about it before in that context, but I also have some childhood trauma from too many blood tests. I can pass out after having blood drawn now and don't know if I'd be able to inject someone. Hopefully yes...
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/ 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).
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.
I'm 90% sure that the SPRY stock history before fall 2022 is actually the stock history of Silverback Therapeutics (trading at SBTX). The two companies merged in fall 2022.
Silverback had raised a pile of cash to push through a cancer drug, but saw their development programs stall out due to poor results.
As for expected market size - you can look at their investor deck. Slide 29(of 33) for their projected unit sales (in probably the most awful graph I've ever seen). You can look at slide 28/33 for market share data of other newly released nasal drugs.
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.
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?
Is there any reason to think that the idea of epi-pens in nasal spray form could only have been conceived of after rescue meds for epilepsy in nasal spray form were approved by the FDA?
> 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.
I’d assume that not only is the market for epipens much larger, but nervous parents will buy multiple of these with the intent of having them stashed all over the place.
But maybe not. Because folks with uncontrolled seizures need rescue meds more often than folks with life-threatening allergies need epi-pens.
Would be interesting to see the data on the potential demand for both products and how they compare.
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.
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.
I see the cost part, but on managing the devices it would either require:
- centralising all the devices in one point and have one or two trained professionals do the injections, which means a significant delay in case of emergency
- or training every professor to do injections, which isn't hard in theory, but time and cost consuming, puts more burden and restrictions on the staff (how do you deal with a 60yo math teacher who just wants to teach and not manage health emergencies ?)
And we're not going into the kids and the school staff properly communicating to get the person in charge to shoot the pen when the kid feel they need it.
Schools already have to solve exactly these problems. Kids with known anaphylactic reactions have an epinephrine autoinjector and possibly a little pack of antihistamines in a baggie, with the kid’s name on it, in the school nurse’s office. And there’s a piece of paper (generally a standard-ish form that may or may not be comprehensible) with specific instructions for that kid. This being America, the kid’s doctor absolutely does not take the time to write clear instructions for that kid.
The only thing that I’m suggesting should change is to have a pile of epinephrine auto injectors (or nose sprays) supplied by the school, so the parents would instead just supply the instructions.
> how do you deal with a 60yo math teacher who just wants to teach and not manage health emergencies
Is that an option? If you're an adult supervising kids over long enough time you will have an emergency. I remember at least 3 decent ones from primary school.
> 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.
Except if there’s overlap in the cause of the incidents that necessitate the usage of the device. Which is very likely in the case of a food allergy driving the event.
Imagine being the principal and trying to explain, with a lot of pretty charts and statistics, why you only hand 6 devices for 12 child patients.
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?
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.
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.
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/
> 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
Readit News
> 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...
> 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
Going to hospital afterwards (to be monitored for late phase reaction and receive high dose antihistamine and hydrocortisone) usually seems to involve putting a cannula in my hand for IV medication which is pretty well guaranteed to be much more unpleasant.
This will allow us to be much more relaxed, since the risk of anyone panicking when administering is lower, the risk of doing it wrong is significantly lower, and the stigmata is also lower compared to a needle.
I've been eagerly awaiting this.
The hard part being, front the patient POV we didn't know if it's in excess of precaution or something really critical.
There's a decent selection of thermo cases that are small enough to make it manageable, but it's definitely a complicating factor, especially for smaller kids.
In my country, injecting a drug via needle is a medical activity only the patient himself, doctor and the nurse instructed by doctor can perform by law.
For EpiPen, the regulation is slightly relaxed so the paramedics, parents/childcare workers/school teachers responsible for the child patient can also use it.
But when the EpiPen is needed, the patients often can't administer himself.
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
[0]: https://ir.ars-pharma.com/news-releases/news-release-details...
I wouldn't be surprised, though, if insurers continue to push generic epinephine injectors ($15-$30) merely from a cost perspective.
https://www.cbc.ca/news/health/epipen-shortage-canada-1.3296...
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.
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.
Deleted Comment
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/ 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).
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.
Silverback had raised a pile of cash to push through a cancer drug, but saw their development programs stall out due to poor results.
https://www.fiercepharma.com/pharma/silverback-admits-defeat...
As for expected market size - you can look at their investor deck. Slide 29(of 33) for their projected unit sales (in probably the most awful graph I've ever seen). You can look at slide 28/33 for market share data of other newly released nasal drugs.
https://ir.ars-pharma.com/static-files/a2079aad-1856-42f9-90...
My bet is that FDA took 5 years longer than reasonable to clear it.
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...
* 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/1671858/000119312523...
I don’t know enough about their history.
> 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.
But maybe not. Because folks with uncontrolled seizures need rescue meds more often than folks with life-threatening allergies need epi-pens.
Would be interesting to see the data on the potential demand for both products and how they compare.
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.
They all come home at the end of the year, expire, repeat.
- centralising all the devices in one point and have one or two trained professionals do the injections, which means a significant delay in case of emergency
- or training every professor to do injections, which isn't hard in theory, but time and cost consuming, puts more burden and restrictions on the staff (how do you deal with a 60yo math teacher who just wants to teach and not manage health emergencies ?)
And we're not going into the kids and the school staff properly communicating to get the person in charge to shoot the pen when the kid feel they need it.
The only thing that I’m suggesting should change is to have a pile of epinephrine auto injectors (or nose sprays) supplied by the school, so the parents would instead just supply the instructions.
Is that an option? If you're an adult supervising kids over long enough time you will have an emergency. I remember at least 3 decent ones from primary school.
Except if there’s overlap in the cause of the incidents that necessitate the usage of the device. Which is very likely in the case of a food allergy driving the event.
Imagine being the principal and trying to explain, with a lot of pretty charts and statistics, why you only hand 6 devices for 12 child patients.
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-appr...
I think they need some differentiating shape or like assigned danger colors for the most common emergency nasal applications.
> 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