Aquestive Therapeutics gets FDA PDUFA date for Anaphylm NDA
Aquestive Therapeutics has confirmed that the US Food and Drug Administration has accepted its resubmitted New Drug Application for Anaphylm (dibutepinephrine) sublingual film, a postage-stamp-sized epinephrine prodrug designed to dissolve under the tongue without water. The agency classified the resubmission as a Class 2 response and assigned a PDUFA goal date of 16 March 2027, giving the Warren, New Jersey-based company a defined regulatory timeline after a difficult year.
The resubmission was filed on 16 September 2026, one month after Aquestive reported positive topline data from human factors and pharmacokinetic studies conducted to address deficiencies identified in the FDA's Complete Response Letter of 30 January 2026. A Class 2 designation indicates the agency intends to review the submission within six months, consistent with the timeline Aquestive had guided to investors.
What the product offers
Anaphylm is a polymer matrix film that delivers epinephrine as a prodrug (dibutepinephrine) via the sublingual mucosa. The device-like packaging is thinner than a credit card and is engineered to withstand temperature and moisture excursions, addressing a practical limitation of existing injectable formats. If approved, Aquestive describes it as the first and only oral rescue medication for Type I allergic reactions, including anaphylaxis.
Daniel Barber, president and chief executive of Aquestive, said the acceptance "gives us a clear path forward," adding that the company was advancing commercial preparations in parallel with the regulatory review. No commercial partner or distribution arrangement was named in the announcement.
In parallel with its US activities, Aquestive said it remains on track to submit a New Drug Submission to Health Canada in the fourth quarter of 2026, extending potential market coverage into Canada ahead of any US launch.
Market and competitive context
The anaphylaxis rescue market has long been dominated by auto-injector formats, most notably branded and generic epinephrine pen devices. Although that segment is mature, it has attracted repeated criticism from patient advocacy groups and healthcare providers over cost, bulkiness and the skill required for correct administration, particularly in paediatric and school settings. A sublingual film format, if it can demonstrate bioequivalence to injected epinephrine in a severe allergic event, would address several of those usability concerns in a single product attribute.
No oral epinephrine product has previously been approved by the FDA for anaphylaxis, which means Aquestive faces the challenge of establishing clinical credibility for a novel delivery route as well as navigating any residual scepticism from the CRL. The company noted in its risk disclosures that the FDA may yet request additional studies or take issue with the interpretation of the human factors and PK data, so investors should treat the PDUFA date as a checkpoint rather than a guaranteed approval event.
Aquestive's broader AdrenaVerse platform contains more than 20 epinephrine prodrug candidates targeting allergy and dermatological indications, including AQST-108 topical gel, which remains at an earlier stage. A successful Anaphylm approval would serve as a meaningful proof of concept for that wider pipeline and could improve the company's leverage in any future licensing or partnership discussions.