Express Rapid-acting treatment of allergic reactions, sublingual administration of epinephrine clinical top line data is eye-catching

Recently, Aquestive Therapeutics announced the positive top-line results
of its EPIPHAST II trial of the adrenaline sublingual agent AQST-109.
The results showed that AQST-109 achieved a significantly faster median time to maximum plasma drug concentration (Tmax) than epinephrine auto-injectors and ordinary intramuscular epinephrine, and repeated administration provided significantly higher
blood concentrations.

An allergic reaction is a severe systemic hypersensitivity reaction that flares quickly and, in severe cases, can be fatal
.
The most common causes of allergic reactions are food (such as peanuts), venom from insect bites, and medications
.
In the event of an allergic reaction, it is extremely important to provide systemic epinephrine more quickly to stop the allergic reaction at an early stage and prevent its progression, as any delay can lead to severe bronchospasm, acute respiratory failure and/or cardiovascular failure, and even death
.

AQST-109 is a polymer-based matrix-based epinephrine prodrug that is a sublingual membrane agent for rapid sublingual delivery of epinephrine
.
The size of the product is similar to that of a stamp, does not require water or swallowing, and dissolves
when placed under the tongue.
The packaging of the AQST-109 is thinner and smaller than a regular credit card, is easy to carry, and can withstand weather variations
such as exposure to rain and/or sunlight.

In the EPIPHAST II trial, the average maximum plasma concentration (Cmax)
of AQST-109 and 0.
3 mg of epinephrine auto-injectors at a single dose, Tmax with 0.
3 mg of epinephrine injected into ordinary intramuscular injections, and repeated doses of AQST-109 and 0.
3 mg of intramuscular epinephrine were compared 。 The results showed that the average time to reach Tmax at a single dose of AQST-109 was significantly faster, at 12 minutes, the average time for an epinephrine auto-injector to reach Tmax was 22.
5 minutes, and the average time for ordinary intramuscular injections to reach Tmax was 45 minutes
.
AQST-109 was significantly higher in blood concentrations for repeated administration, with a Tmax of 8 min after administration and extensive absorption
was observed.
The mean Cmax of AQST-109 is 465 pg/mL after one administration and 2958 pg/mL after two administrations
.
The Cmax after intramuscular injection of 0.
3 mg of epinephrine was 489 pg/mL after one dose and 911 pg/mL after two doses
.
The Cmax after one-time administration of an epinephrine autoinjector is 869 pg/mL
.

In addition, single-dose AQST-109 is similar
to changes in systolic blood pressure and heart rate after single-dose epinephrine auto-injector administration.
After the patient receives one dose of AQST-109, the maximum average effect on systolic blood pressure occurs within 5 minutes after administration, compared with 8 minutes for an epinephrine auto-injector; The maximum average effect of AQST-109 on heart rate occurs within 8 minutes of administration, compared to 5 minutes
for an epinephrine auto-injector.
The safety results of AQST-109 were in line with expectations, with no serious adverse events
reported.

"We are pleased to see that AQST-109 outperforms both injectable epinephrine on multiple indicators," said Mr.
Daniel Barber, CEO of Aquestive, "which allows us to take a meaningful step
forward in helping to improve the lives of people looking for alternative options for standard care for current allergic reactions.
" We believe that AQST-109 will provide a meaningful supplement for the treatment of allergic reactions
.
”

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