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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

#31

Post by AbstractH24 »

sweca wrote: post #24
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…

neffy is priced at $99.50 per unit. > 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.

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

#32

Post by _heimdall »

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?

[1] https://www.fda.gov/news-events/press-announcements/fda-appr...

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

#33

Post by icegreentea2 »

BurningFrog wrote: post #22
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…

> My first question is what took so long? My bet is that FDA took 5 years longer than reasonable to clear it.

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.

* 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...

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

#34

Post by AbstractH24 »

BurningFrog wrote: post #22
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…

> My first question is what took so long? My bet is that FDA took 5 years longer than reasonable to clear it.

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?

I don’t know enough about their history.

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

#35

Post by toomuchtodo »

NavinF wrote: post #27
toomuchtodo wrote: post #21

Earlier quoted context omitted.

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 con…

> 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.

https://www.biopharmadive.com/news/how-mylan-ended-up-with-a...

https://kffhealthnews.org/news/behind-the-epipen-monopoly-lo...

https://www.courthousenews.com/10th-circuit-asked-to-revive-...

https://www.reuters.com/legal/litigation/pfizer-pay-50-mln-s...

https://www.nbcnews.com/business/business-news/epipen-maker-...

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

#36

Post by AbstractH24 »

icegreentea2 wrote: post #33
BurningFrog wrote: post #22

Earlier quoted context omitted.

> My first question is what took so long? My bet is that FDA took 5 years longer than reasonable to clear it.

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 informa…

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.

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

#37

Post by odyssey7 »

BurningFrog wrote: post #26
floam wrote: post #20

Earlier quoted context omitted.

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…

I'm convinced a lot of "antivaxxery" is simply redirected needle phobia.

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.

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

#38

Post by icegreentea2 »

AbstractH24 wrote: post #36
icegreentea2 wrote: post #33

Earlier quoted context omitted.

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 informa…

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.

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

#39

Post by recursivegirth »

odyssey7 wrote: post #37
BurningFrog wrote: post #26

Earlier quoted context omitted.

I'm convinced a lot of "antivaxxery" is simply redirected needle phobia.

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.

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