At present’s FDA-approved emergency epinephrine gadgets used to deal with anaphylaxis all make use of a needle to ship the drug into the muscular tissues of the outer thigh. For some, the concern of a needle jab could also be a barrier to administering epinephrine, and delayed administration of epinephrine results in poorer outcomes.
One other barrier to the administration of epinephrine is the excessive value of these emergency epinephrine gadgets, which, relying on insurance coverage protection, can run as much as a whole lot of {dollars} per pair within the US. Contemplating meals allergy victims are inspired to hold two gadgets always and school-age youngsters should usually depart an auto-injector with their nurse for the college 12 months, the associated fee is usually prohibitive. And present gadgets usually expire in a 12 months or much less in the event that they’ve been sitting on a pharmacist’s shelf.
Nonetheless one other barrier is kind issue: the gadgets may be cumbersome and tough to hold, particularly for individuals who don’t carry a handbag.
These limitations lead many who’ve efficiently averted reactions for a time to grow to be lax in carrying epinephrine. However being caught with out the drug when anaphylaxis strikes could be a lethal mistake.
There are presently plenty of emergency epinephrine alternate options in numerous levels of scientific trials on their solution to FDA approval. Listed here are those we’ve been maintaining a tally of.
Aquestive Therapeutics — AQST-109
Aquestive first appeared on our radar in 2018 with a skinny, postage-stamp-sized movie formulation of epinephrine that’s positioned below the tongue the place it rapidly dissolves and is absorbed into the bloodstream.
Trials have proven that AQST-109 shows absorption charges and blood concentrations which are in line and may very well enhance upon related traits of epinephrine auto-injectors.
Learn extra about AQST-109.
ARS Prescription drugs — Neffy™
We first realized ARS was creating an epinephrine nasal spray in 2019. The machine guarantees an “easy-to-use, needle-free, handy and extra dependable therapy for extreme allergic reactions to meals, drugs and bug bites that would result in life-threatening anaphylaxis.”
The main query concerning Neffy, whether or not the epinephrine it delivers may be correctly absorbed if the person suffers from nasal congestion, was answered when assessments concluded the drug is definitely absorbed even higher in such circumstances.
Neffy stands out as the first needle-free emergency epinephrine choice to be accepted by the FDA, anticipated within the second half of 2024.
Learn extra about Neffy.
Bryn Pharma — BRYN-NDS1C
Bryn Pharma additionally has an intranasal epinephrine machine in scientific trials that, like Neffy, has been fast-tracked by the FDA.
Though the shape issue differs, the idea behind BRYN-NDS1C is comparable: ship epinephrine by way of a superb spray that’s rapidly absorbed within the nasal passages and delivered by way of the bloodstream.
Learn extra about BRYN-NDS1C.
Nasus Pharma — FMXIN002
One other intranasal machine, FMXIN002 works otherwise in that it shops and delivers epinephrine in powder kind. Nasus claims their machine “can present a safer and simpler rescue for the emergency therapy of life-threatening allergic reactions by offering an easy-to-use machine and faster absorption of Epinephrine.”
Learn extra about FMXIN002.
Orexo AB — OX640
Orexo first appeared on our radar in 2024 within the lead-up to the AAAAI 2024 assembly. This firm can also be in trials with a powder type of epinephrine delivered by way of the proprietary AmorphOX drug supply platform that guarantees an extended shelf life and decreased temperature sensitivity.
Learn extra about OX640.
Crossject — Zeneo
Zeneo is an auto-injector that delivers epinephrine intramuscularly however does so by using a needle-less mechanism.
The machine consists of a specifically designed glass tube that may face up to excessive strain together with a propellant primarily based on a nitrocellulose chemical response. When activated, the machine propels epinephrine below excessive strain via the pores and skin into the bloodstream, obviating the necessity for a needle.
Learn extra about Zeneo.
pHase Prescription drugs
pHase was issued US patent #11,253,488 in 2022 for a sublingual epinephrine pill.
The patent summary states: “The current disclosure offers sublingual epinephrine tablets and strategies of treating anaphylaxis, strategies for concomitant remedy throughout a cardiac occasion, treating hypoglycemia, and prophylaxis for immunotherapy, utilizing sublingual epinephrine tablets.”
The corporate claims to have “found a novel, neural pathway and underlying mechanism of motion. This new science is obvious in pHase’s research and reveals that pHase’s patented sublingual formulation is simpler, safer and achieves higher outcomes than different supply mechanisms.”
Learn extra about pHase.
Have you learnt of different emergency epinephrine alternate options presently on the horizon not listed right here? Tell us.
