4 ms·

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 m

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?
    - modeless 2y ago
      This is a medical product. It's sold for like 100x cost. It'll still be more than worth it.
      - tgma 2y ago
        Assuming they were going to do that, it'd likely still be much cheaper to trade the old one in and discard it and get a new one.
  - ralferoo 2y ago
    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.
    - modeless 2y ago
      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.
sweca 2y ago
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.
- fluidcruft 2y ago
  It also looks to be much smaller
  - modeless 2y ago
    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. Edit: Found a picture of an official case. Carries two doses and looks roughly similar in size to two Auvi-Q doses: https://andersresearch.substack.com/p/aquestive-therapeutics-aqst-underappreciated https://andersresearch.substack.com/p/aquestive-therapeutics... 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.
    - fluidcruft 2y ago
      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.
- tomatocracy 2y ago
  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.
makeitdouble 2y ago
> Obviously very few people do that. 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.
ezoe 2y ago
The needle-less part is important. 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.
- viraptor 2y ago
  Which country is that?
  - ezoe 2y ago
    Japan.
LUmBULtERA 2y ago
I wasn't aware of the relatively low max temp spec of the epipens. Yikes, a big thank you for pointing that out.
retSava 2y ago
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. I've been eagerly awaiting this.
- mrbombastic 2y ago
  nit: stigmata -> stigma.
  - Wevah 2y ago
    Yes: “Stigmata” is the (a) plural of “stigma”.
    - retSava 2y ago
      Aaaahh! Thank you both!

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?
  - modeless 2y ago
    This is a medical product. It's sold for like 100x cost. It'll still be more than worth it.
    - tgma 2y ago
      Assuming they were going to do that, it'd likely still be much cheaper to trade the old one in and discard it and get a new one.
- ralferoo 2y ago
  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.
  - modeless 2y ago
    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.

sweca 2y ago

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.

fluidcruft 2y ago
It also looks to be much smaller
- modeless 2y ago
  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. Edit: Found a picture of an official case. Carries two doses and looks roughly similar in size to two Auvi-Q doses: https://andersresearch.substack.com/p/aquestive-therapeutics-aqst-underappreciated https://andersresearch.substack.com/p/aquestive-therapeutics... 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.
  - fluidcruft 2y ago
    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.
tomatocracy 2y ago
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.

makeitdouble 2y ago

> Obviously very few people do that. 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.

ezoe 2y ago

The needle-less part is important. 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.

viraptor 2y ago
Which country is that?
- ezoe 2y ago
  Japan.

LUmBULtERA 2y ago

I wasn't aware of the relatively low max temp spec of the epipens. Yikes, a big thank you for pointing that out.

retSava 2y ago

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. I've been eagerly awaiting this.

mrbombastic 2y ago
nit: stigmata -> stigma.
- Wevah 2y ago
  Yes: “Stigmata” is the (a) plural of “stigma”.
  - retSava 2y ago
    Aaaahh! Thank you both!