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Aquestive’s Anaphylm for Severe Allergic Reactions Shows Promise in Children
Aquestive’s Anaphylm study showed positive pharmacokinetic results in children and adolescents, supporting its FDA submission.
This morning on April 1, 2025, Aquestive Therapeutics announced positive topline pharmacokinetic results from a study assessing Anaphylm (epinephrine) sublingual film in patients aged 7 – 17 years weighing > 30 kilograms with a history of allergic reactions.
This concludes the Anaphylm clinical program, with this trial being the last one included in the New Drug Application (NDA) submission Aquestive recently sent to the US Food and Drug Administration (FDA). The NDA is anticipated to be accepted in the second quarter of 2025.
“We are extremely pleased with the positive results from our pediatric study, which further validate Anaphylm's potential as the first-ever sublingual film and convenient treatment option for all patients with severe allergic reactions, including anaphylaxis," said Daniel Barber, president and CEO of Aquestive, in a statement. "These results demonstrate that Anaphylm maintains its consistent [pharmacokinetic] profile in pediatric patients between the ages of seven and seventeen and weighing greater than thirty kilograms.”
This multi-site, single treatment study evaluated the pharmacokinetics, pharmacodynamics, safety, and tolerability of Anaphylm in 32 children aged 7 – 17 years. The results were consistent with previous adult studies in terms of pharmacokinetics and safety.
The results showed that children and adolescents had a mean baseline-adjusted epinephrine concentration over time of about 280 pg/mL at 10 minutes after the administration of Anaphylm 12 mg, compared with about 330 pg/mL for adults.
Anaphylm is a polymer matrix-based epinephrine prodrug product candidate in development for the treatment of severe allergic reactions, such as anaphylaxis. This product is about the size of a postage stamp, weighs less than an ounce, and dissolves on contact—water or swallowing is not needed.
The company also said the Anaphylm package is thinner and smaller than an average credit card and can withstand exposure to rain or sunlight. The FDA has conditionally approved Anaphylm’s trade name for AQST-109.
“These data are an important component of the FDA review process and could enable Anaphylm to have a label that includes this pediatric patient population,” Barber continued. “We continue to prepare for commercial readiness and plan to launch Anaphylm in the first quarter of 2026, if approved by the FDA.”
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