I did a fast read through of the FDA advisory committee's report. The FDA's request for a new trial is for "real world" multiple dosing of Neffy in comparison to a rival injected product. One cannot ethically do that in the case of anaphylactic shock as outlined in the advisory committee's report. So it would be done in a lower level allergic reaction.
As outlined in the report a second dose is most often needed because of a delay in administration of a first dose. That delay would be less likely with a nasal spray. The data from Neffy's trials also show that Neffy takes effect faster than intramuscular injection and comparable to Epipen. The report also shows that there is a more stable pharmacokinetic reaction from Neffy than either Epipen type devices or IM so a second dose carries less risk and multiple doses would have favorable outcomes.
So the FDA has data from multiple dosing already.
In other words it sure looks like the FDA is sandbagging another product in favor of big pharma.
As outlined in the report a second dose is most often needed because of a delay in administration of a first dose. That delay would be less likely with a nasal spray. The data from Neffy's trials also show that Neffy takes effect faster than intramuscular injection and comparable to Epipen. The report also shows that there is a more stable pharmacokinetic reaction from Neffy than either Epipen type devices or IM so a second dose carries less risk and multiple doses would have favorable outcomes.
Quote:Overall in all Neffy studies there were approximately 600 subjects and over 1120 doses of product with both once and twice dosing.
Twice dosing in the ARS primary studies with neffy 2 mg giving a total dose of 4 mg epinephrine in 10 minutes, resulted in 100% of events being mild and expected for epinephrine. There were no moderate or severe events with neffy 2 mg given twice. There was 1 moderate
event in 1 subject with 0.3 mg IM given twice, which was vomiting.
Overall, the safety profile of neffy 2 mg was benign with >95% of events being mild common events and all events similar to IM injection. There was no dose related increase in adverse
events with repeated doses of neffy 2 mg up to 4 mg.
https://www.fda.gov/media/167989/download
So the FDA has data from multiple dosing already.
In other words it sure looks like the FDA is sandbagging another product in favor of big pharma.
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