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0 pointsicegreentea21y ago0 comments

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...

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...

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AbstractH241y ago· 2 in thread

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.

icegreentea2OP1y ago

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.

AbstractH241y ago

Fascinating, thanks for taking the time to look into it

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