February 2, 2026 – Acquistem Therapeutics announced that it had received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on January 30, 2026, in response to the New Drug Application (NDA) filed for Anaphylm™ (dibutadrenaline) sublingual film. The NDA was submitted to seek FDA approval for the treatment of Type I hypersensitivity reactions, including anaphylaxis, in patients weighing 30 kilograms (approximately 66 pounds) or more.
The only critical deficiencies identified by the FDA pertain to the product’s packaging and administration.
The Company believes these deficiencies can be resolved expeditiously and expects to resubmit the NDA as early as the third quarter of 2026.
Acquistem maintains a robust financial position and anticipates holding sufficient cash reserves through the end of 2026.
It reaffirmed its plan to file Marketing Authorization Applications (MAAs) in Canada and the European Union by the end of 2026.
In connection with the requirements for human factors studies, the FDA’s Division of Clinical Pharmacology requested the Company to conduct an additional pharmacokinetic (PK) study to characterize the impact of any adjustments to the product’s packaging and labeling on the drug. The FDA also stated that the human factors study and the PK study may be conducted concurrently. No other additional studies were requested by the FDA for this NDA submission.
Anaphylm™ (dibutadrenaline) Sublingual Film
Anaphylm is an investigational epinephrine prodrug based on a polymer matrix. Roughly the size of a postage stamp and weighing less than one ounce, the film initiates dissolution upon contact with the oral mucosa, requiring no water or swallowing for administration. Its primary packaging is thinner and smaller than a standard credit card, offering exceptional portability, and features superior weather resistance, capable of withstanding outdoor conditions such as rain and direct sunlight. Anaphylm, the proposed brand name for AQST-109, has received conditional approval from the FDA, with the final authorization of the brand name contingent upon the FDA’s approval of the drug product itself.
About Acquistem Therapeutics
Acquistem Therapeutics is an innovative pharmaceutical company that leverages cutting-edge science and drug delivery technologies to develop therapeutics that deliver meaningful improvements to patients’ lives. The Company specializes in the development of oral delivery products that enable the effective delivery of complex molecules, providing novel alternatives to invasive and inconvenient standard-of-care therapies. Currently, the Company has four licensed commercial products marketed by authorized partners in the U.S. and global markets, and it serves as the exclusive manufacturer of these products. Additionally, Acquistem collaborates with a number of pharmaceutical enterprises to advance the commercialization of New Molecular Entities (NMEs) by leveraging its proprietary, world-leading technologies including its film drug delivery platform, and possesses well-established drug development and commercialization capabilities. The Company is currently advancing the development of a late-stage proprietary investigational drug for the treatment of severe allergic reactions including anaphylaxis, as well as an early-stage investigational topical epinephrine prodrug gel for the treatment of alopecia areata and other dermatological disorders.
WeChat
WhatsApp
