[mv]

It is absolutely criminal that a <$20 drug can be sold for $4500... Auto-injectors have been a solved problem for decades, and there is nothing special about naloxone vs any other drug. Treating auto-injecting tech as different for each drug only helps drive up prices and keep out competition by making FDA approval very expensive.

I hope you are successful getting a generic auto-injector approved, but I don't think your biggest hurdle will be design or engineering.

https://www.nejm.org/doi/full/10.1056/NEJMp1609578

[DanBC]

> Auto-injectors have been a solved problem for decades,

And yet we still have stuff like this: https://www.judiciary.uk/publications/natasha-ednan-laperous...

>(3) In the Emergency treatment of anaphylactic reactions Guidelines for healthcare providers the preferred needle length is 25 mm for adrenaline injectors to access muscle in most people. I heard during expert evidence that Epipen needle length was 16mm - suitable according to the UK Resuscitation Council for “pre-term or very small infants”. The use of needles which access only subcutaneous tissue and not muscle is in my view inherently unsafe. An alternative autoinjector, Emerade has a 24 mm needle.

>(4) The dose of adrenaline in Epipen is 300mcg. The UK Resuscitation Council recommends a standard emergency dose of 500mcg. Emerade contains a dose including 500mcg. The combination of what my expert told me was an inadequate dose of adrenaline for anaphylaxis and an inadequate length needle raises serious safety concerns.

[mv]

The Auto-injector's themselves are a solved problem and the device itself did not fail. However,

-For over 10 years, It well documented in literature that even in normal BMI women the needle is not long enough to reach muscle. https://www.ncbi.nlm.nih.gov/pubmed?term=15945556

- Prior to around 2003 IM and subcutaneous routes were both listed as valid treatments for anaphylaxis. (See https://www.aafp.org/afp/2003/1001/p1325.html)

-Depending on her weight 300mcg may be an appropriate dose for US guidelines (listed at 0.01mg/kg).

The listed issues may be from a company taking a 'one-size-fits-most' approach. They also do not update their product with respect to new guidelines and recommendations (new doses, new needle lengths, etc) Possibly to avoid further FDA approval processes? With such large profits and so little competition there is no incentive to innovate/update.