The resubmission follows an FDA Complete Response Letter and cites human factors data showing pouch-opening time fell from 17 to 3 seconds.
Aquestive Therapeutics has resubmitted its New Drug Application (NDA) to the
According to Aquestive, the CRL requested a human factors study addressing packaging and administration along with a confirmatory pharmacokinetic (PK) study.¹ The company originally submitted its NDA for Anaphylm in March 2025 and held a Type A meeting with the FDA to align on its response strategy after receiving the CRL.¹ Anaphylm previously demonstrated pharmacodynamic responses comparable to or greater than auto-injectors and manual intramuscular (IM) epinephrine in prior clinical studies.¹
"When a patient experiences an anaphylactic reaction, rapid access to and administration of epinephrine are critically important," said David B.K. Golden, MD, CM, lead author of the 2023 Anaphylaxis Practice Parameter and member of Aquestive's Scientific Advisory Board. "A small, highly portable, and needle-free treatment option has the potential to address important barriers associated with carrying and administering epinephrine."¹
According to Aquestive, the human factors study evaluated revised packaging incorporating modifications to the pouch opening, instructions for use, and pouch and carton labeling.² The redesign reduced median pouch-opening time from 17 seconds to 3 seconds.² The company also completed a confirmatory PK study in healthy volunteers using the revised packaging and instructions, evaluating both self-administration and clinician administration of Anaphylm, with manual IM epinephrine included as a comparator.¹
No protocol-defined use errors were observed in the self-administration arm of the PK study, according to the company.¹ Aquestive said the completed studies generated human factors, pharmacokinetic, and pharmacodynamic data supporting the revised packaging design and instructions for use.¹ The FDA will determine the resubmission's classification and establish a review timeline following its initial review.¹
Anaphylm is designed to dissolve on contact without water or swallowing, and its primary packaging is thinner and smaller than a credit card, sized to fit in a pocket and withstand weather exposure such as rain and sunlight, according to Aquestive.¹
The Anaphylm trade name for AQST-109 has received conditional FDA approval, with final approval of the proprietary name contingent on approval of the product candidate itself.¹ Aquestive is preparing for an allergist-first commercial launch if Anaphylm receives approval, citing urgency to reach patients who need reliable epinephrine access.¹
"This resubmission reflects the rigor of our response to the FDA's Complete Response Letter, and we believe it addresses the items identified by the FDA in the Complete Response Letter," said Daniel Barber, President and CEO, Aquestive Therapeutics. "…we are moving with urgency to bring Anaphylm to the patients who need it most."¹
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