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.
There's little point in re-certifying, because if the pens only contain 80% of the dose in these conditions, they will almost certainly fail the certification in those conditions. They presumably contain the dose they do to ensure that device is as safe as possible - so that it's high enough that it can save the patient in almost every case but low enough to not cause other issues or side-effects.
What that third-party test shows is that if all you have available is a supposedly 4-year past-expiry pen and it's been kept at all the wrong temperatures, you should probably still use it in an emergency because there's a good chance it will still work. Not a big enough chance that they recommend using expired pens, but enough that if the choice is probably dying or using it, you absolutely should use it.
Of course you should try an expired EpiPen if that's all you have during an emergency. But that doesn't mean you should ignore the storage temperature requirements for EpiPens, even if they are currently a bit conservative, and Neffy's better performance in high temperatures is a huge advantage.
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.
It does look a whole lot smaller than an Epi-Pen in its plastic case. But Auvi-Q (existing epipen alternative) is also much smaller. I don't see any pictures of the neffy case; surely you have to carry it in a case just like the others.
I bet a third party could make a smaller case than that, though. I also expect that neffy is much lighter, as Auvi-Q has a battery and a speaker and a needle and a spring and whatnot.
Good point. Neffy is said to use the same hardware narcan uses, and some googling of images for narcan just has it inside a tear open paper/plastic laminated wrapper.
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...
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.
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.
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.
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.
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-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
> 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.
Because options prevent further monopoly activity that was proven to have happened (citations provided). You seem to have some interest in avoiding the truth and facts around this topic, which is odd. First “there was no monopoly,” and then “well, it was a while ago so it doesn’t matter now.” It happened, and it could happen again. Also, it isn’t enough to be generic based on manufacturing complexity and capacity, which can create a monopoly situation for a generic.
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?
How novel is the idea of delivering prescription emergency meds via nasal spray?
I only know of their existence because I’ve used them for epilepsy personally. Are there any other contexts they’re used other than that and now this? They’ve obviously been used outside of emergencies for decades.
If it was completely revolutionary when it was brought to market for epilepsy then it makes sense.
From digging, Valtoco (the epilepsy nasal spray) was the second drug approved using "intravail", an excipient used to boost drug absorption through the nasal membrane. Valtoco was approved in 2020 (drug approval was submitted in 2018-2019 and fast track granted back in 2016/2017), with a development cycle that appears to have started back in 2007/08.
The first drug approved using intravail was tosymra (for migraines) and was approved in 2018. Intravail itself seems to have been around since at least 2006.
This drug (neffy) also uses intravail.
I would speculate that intravail (or an excipient like it) is probably required for rapid/acute/emergency situations. My expectation is that the first approval of a nasal drug using intravail would have greatly reduced the hurdles for any subsequent drug.
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 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?
Their complaint isn't that the school is stocking them. Their complaint is that each child that needs one available is required to provide a personal one to the school to store for use in case they have an emergency.
So instead of the school managing and restocking a reasonable number, the parents restock one each year.
Wouldn't the "reasonable number" to stock be the same? Let's say there's 8 kids that need the EpiPen. If there was a food allergy incident, it could be something like a school lunch event which means they need at least enough for every kid since they might all get the same reaction from all eating the same food. From reading these replies it looks like you need 2 for each person just in case they require a second dose, and replace them once a year.
So:
- if school stocks them for 8 kids: they need to replace 16 every year
- if the 8 kids families supply the stocks: they need to, in aggregate, replace 16 every year
Same amount. Obviously better if the school pays, but I'm not understanding the "reasonable number" part.
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.
We've seen these kind of settings, but some schools will refuse a kid with "special needs" and punt it to bigger/more prepared schools, while others won't go the full length.
We were in one that couldn't provide meals (kid comes with it's own lunch, and they can't touch anything else) and individual medication was on a special cabinet in the classroom, but accessed by the kids.
TBH it felt more reassuring to us, as we only had to care about our kid properly reacting, and not about a whole chain of events we have no idea how well a generic school prepares for.
> 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.
The moment you put a system in place where the teacher isn't acting on its own as a human being in an unforeseen situation, but as the guardian of the cabinet where all the EpiPen are stored, you're required to codify who and under which circumstances gets access, who shoots, etc. Basically the organization gets involved as it sets the rules, and it's where the finger will be pointed when it all goes for the worse.
This is the primary reason it's the kid and the parents who are in charge, that's the discussion we had with the school staff.
> 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
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.
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.
> 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...