Aquestive resubmits Anaphylm NDA after human factors and PK studies

Aquestive Therapeutics has resubmitted its New Drug Application to the US Food and Drug Administration for Anaphylm (dibutepinephrine) sublingual film, a needle-free epinephrine treatment for Type I allergic reactions including anaphylaxis. The Warren, New Jersey company filed the original NDA in March 2025, but received a Complete Response Letter in January 2026 requesting additional human factors and pharmacokinetic data before the agency would consider approval.

The resubmission is supported by two studies completed in the intervening months. The human factors study evaluated revised packaging with modifications to the pouch opening, labelling, and instructions for use. A key outcome was a reduction in median pouch-opening time from 17 seconds to 3 seconds, a change the company says materially improves usability in an emergency setting. A confirmatory PK study in healthy volunteers, which included manual intramuscular epinephrine as a comparator, found no protocol-defined use errors in the self-administration arm.

Regulatory path

The FDA will now determine how to classify the resubmission, which affects the applicable review timeline. A Class 1 classification typically carries a two-month review period; a Class 2 classification allows six months. Aquestive has not speculated publicly on which classification it expects, and the FDA has not yet issued a goal date. Following receipt of the CRL, Aquestive held a Type A meeting with the agency to align on its approach, which it says underpins its confidence that the resubmission addresses the deficiencies identified.

Daniel Barber, president and chief executive of Aquestive, said the completed studies "generated human factors, pharmacokinetic, and pharmacodynamic data supporting the revised packaging design and instructions for use" and that the company was moving with urgency to prepare for an allergist-first commercial launch, contingent on approval.

Advisory board member David B.K. Golden, lead author of the 2023 Anaphylaxis Practice Parameter, noted that Anaphylm had previously demonstrated pharmacodynamic responses, including increases in heart rate and blood pressure, that were "comparable to or greater than those observed with auto-injectors and manual IM epinephrine in clinical studies."

Market context

The anaphylaxis treatment market is dominated by auto-injector formats, principally the EpiPen franchise and its generic equivalents, which have faced persistent criticism over size, cost, and barriers to patient adherence. A sublingual film format, roughly the size and weight of a postage stamp and small enough to fit in a standard pocket, would directly address the portability and needle-aversion concerns that clinicians frequently cite as reasons patients fail to carry their prescribed epinephrine.

Regulatory precedent in this space is limited. Sublingual delivery of epinephrine presents bioavailability challenges that have historically complicated regulatory review, which is consistent with the FDA's request for the confirmatory PK study. Aquestive's AdrenaVerse platform holds a library of more than 20 epinephrine prodrugs, providing some pipeline optionality should Anaphylm face further regulatory hurdles. A second asset, AQST-108, an epinephrine topical gel targeting dermatological conditions, is also in development.

The company operates both as a proprietary drug developer and as a contract development and manufacturing organisation, providing a degree of revenue diversification. Investors will focus on the FDA's classification decision and the subsequent goal date as the next meaningful catalysts for the NASDAQ-listed stock.