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.
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.