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US FDA approves nasal spray alternative to EpiPen for allergic reactions

reuters.com

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

#41

Post by labster »

modeless wrote: post #25
NavinF wrote: 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.

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?

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

#42

Post by odyssey7 »

recursivegirth wrote: post #39
odyssey7 wrote: post #37

Earlier quoted context omitted.

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…

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.

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

#43

Post by icegreentea2 »

AbstractH24 wrote: post #17

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 recoverin…

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.

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...

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

#44

Post by AbstractH24 »

icegreentea2 wrote: post #38
AbstractH24 wrote: post #36

Earlier quoted context omitted.

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)…

Fascinating, thanks for taking the time to look into it

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

#45

Post by modeless »

labster wrote: post #41
modeless wrote: post #25

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.

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.

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

#47

Post by fluidcruft »

sweca wrote: post #23
modeless wrote: post #13

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.

It also looks to be much smaller

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

#48

Post by modeless »

fluidcruft wrote: post #47
sweca wrote: post #23

Earlier quoted context omitted.

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.

It also looks to be much smaller

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...

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.

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

#49

Post by fluidcruft »

modeless wrote: post #48
fluidcruft wrote: post #47

Earlier quoted context omitted.

It also looks to be much smaller

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... I b…

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.

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

#50

Post by modeless »

sweca wrote: post #46
nhyun wrote: post #40

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

Haven't heard of that one. But neffy uses 3 mg of epinephrine.

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...
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