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US FDA approves nasal spray alternative to EpiPen for allergic reactions

reuters.com

51–60 of 86 posts

Re: US FDA approves nasal spray alternative to EpiPen for allergic reactions

#51
post #41

Earlier quoted context omitted.

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?

This is a medical product. It's sold for like 100x cost. It'll still be more than worth it.

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.

Re: US FDA approves nasal spray alternative to EpiPen for allergic reactions

#52

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 degr…

> 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.

Re: US FDA approves nasal spray alternative to EpiPen for allergic reactions

#53
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.

Re: US FDA approves nasal spray alternative to EpiPen for allergic reactions

#54

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 degr…

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.

Re: US FDA approves nasal spray alternative to EpiPen for allergic reactions

#55
post #9

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…

Liability. Not gonna happen.

Re: US FDA approves nasal spray alternative to EpiPen for allergic reactions

#56
post #9

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…

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.

Re: US FDA approves nasal spray alternative to EpiPen for allergic reactions

#57
post #53

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.

Re: US FDA approves nasal spray alternative to EpiPen for allergic reactions

#58
post #18

Earlier quoted context omitted.

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-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

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.

Re: US FDA approves nasal spray alternative to EpiPen for allergic reactions

#59

Earlier quoted context omitted.

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-par…

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.

Re: US FDA approves nasal spray alternative to EpiPen for allergic reactions

#60
post #23

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 degr…

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.

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