Aquestive Resubmits Anaphylm New Drug Application Following New FDA-Requested Studies

Key Points

• Aquestive Therapeutics has resubmitted its New Drug Application for Anaphylm™, a needle-free epinephrine treatment candidate for severe allergic reactions, including anaphylaxis.
• The resubmission follows an FDA Complete Response Letter issued in January 2026 that requested additional packaging, administration, and pharmacokinetic data.
• Aquestive redesigned the product’s pouch and instructions for use, reducing median opening time from 17 seconds to 3 seconds.
• The company said its confirmatory study found no protocol-defined use errors among participants who self-administered Anaphylm.
• If approved, Aquestive plans to launch Anaphylm first through allergists.

Aquestive Therapeutics (NASDAQ: AQST) has resubmitted its New Drug Application, or NDA, for Anaphylm after completing the studies requested by the U.S. Food and Drug Administration.

Anaphylm is a small, needle-free epinephrine film designed to be placed under the tongue during severe allergic reactions, including anaphylaxis. The company said the resubmission includes data supporting improved packaging and updated instructions intended to make the product easier to access and administer.

FDA Requested Additional Anaphylm Packaging and Administration Data

Aquestive originally submitted its NDA for Anaphylm in March 2025. In January 2026, the FDA issued a Complete Response Letter requesting two additional studies: a human-factors study focused on packaging and administration, and a confirmatory pharmacokinetic study.

The company later met with the FDA to discuss how it planned to address the agency’s requests before completing the required studies.

Redesigned Pouch Opens Faster During a Medical Emergency

Aquestive revised Anaphylm’s pouch-opening design, instructions for use, pouch labeling, and carton labeling.

The company said the redesigned package reduced the median time needed to open the pouch from 17 seconds to 3 seconds. This could be important during an anaphylactic reaction, when rapid access to and administration of epinephrine are critical.

The company said the completed human-factors, pharmacokinetic, and pharmacodynamic studies support the revised product design.

Confirmatory Study Found No Defined Self-Administration Errors

The confirmatory pharmacokinetic study was conducted in healthy volunteers using the revised packaging and instructions.

It evaluated Anaphylm when used by participants themselves and when administered by clinicians. The study also included manual intramuscular epinephrine as a comparison.

According to Aquestive, no protocol-defined use errors were reported in the group that self-administered Anaphylm.

Anaphylm Aims to Provide a Portable Needle-Free Epinephrine Option

Anaphylm is being developed as a portable alternative to injectable epinephrine for Type I allergic reactions, including anaphylaxis.

The company said prior clinical studies showed rapid onset and increases in heart rate and blood pressure that were comparable to or greater than those observed with epinephrine auto-injectors and manually administered intramuscular epinephrine.

Aquestive plans a focused, allergist-first launch if the FDA approves Anaphylm. The product remains investigational and has not yet received FDA approval.