The efficiency of AQST-109 — the thin-film epinephrine delivered sublingually — was corresponding to conventional modes of supply based on knowledge offered at this yr’s American Academy of Allergy, Bronchial asthma & Immunology Annual Assembly.
AQST-109 is completely different from auto-injectors and syringes in that there isn’t any needle concerned. The epinephrine is delivered through a small movie positioned below the tongue that dissolves rapidly in saliva and is absorbed within the mouth.
Mentioned Dr Matthew Greenhawt, director of the meals problem and analysis unit at Youngsters’s Hospital Colorado:
AQST may very well signify a considerable therapy development for sufferers in danger for anaphylaxis as a result of it may be extra readily carried than a device-based epinephrine product.
This postage stamp-sized product could be carried in a pockets, your pocket or in a small purse — locations which can be just a little bit tougher for an autoinjector to suit
24 wholesome adults (13 ladies; imply age, 35 years; age vary, 24-49 years; 33% white) participated within the section 1 scientific examine. Members every obtained a 12mg dose of AQST-109, a 0.3mg dose of epinephrine administered intramuscularly through syringe, and a 0.3mg dose delivered intramuscularly through epinephrine EpiPen-brand auto-injectors.
Researchers then took blood plasma samples earlier than every dose and steadily as much as 8 hours after administration to find out how AQST-109 in comparison with conventional technique of epinephrine administration.
Though EpiPen produced the next focus of epinephrine (744.2 pg/mL) than AQST-109 (294 pg/mL) and syringe (411.2 pg/mL), AQST-109 had a a lot shorter time to most focus (12 minutes) than EpiPen (23 minutes) and syringe (45 minutes).
When wanting on the space below the curve [AUC] values, the AQST-109 movie fell between increased AUC for the EpiPen gadget and decrease AUC for the handbook injection when measured over a vital interval of as much as half-hour.
The researchers noticed early and strong will increase in systolic and diastolic blood strain and pulse with AQST-109 reflecting the sooner absorption when put next with EpiPen and syringe. Elevating blood strain — vital to stabilizing sufferers present process anaphylaxis — was strongest with AQST-109 within the first jiffy regardless of the upper focus achieved with EpiPen.
By way of security and tolerability, most hostile occasions have been per the identified physiologic results of epinephrine throughout the remedies.
There have been no vital treatment-related hostile results reported. People who have been reported have been delicate, transient, and resolved with minimal intervention.
The outcomes right here add to the physique of proof indicating that AQST-109 exhibits promise as a viable, noninvasive and easy-to-carry various to device-based epinephrine supply merchandise for the therapy of anaphylaxis.