Aquestive’s Anaphylm NDA Resubmission Accepted by FDA

Aquestive Therapeutics has secured FDA acceptance of its resubmitted New Drug Application (NDA) for Anaphylm (dibutepinephrine) sublingual film, an investigational epinephrine-based treatment for severe allergic reactions, including anaphylaxis. The FDA classified the resubmission as a Class 2 response and set a Prescription Drug User Fee Act (PDUFA) target action date of March 16, 2027.

The regulatory milestone advances Anaphylm toward a potential US decision following deficiencies identified in an earlier review. If approved, the product could offer an alternative to injectable epinephrine devices for emergency treatment of severe allergic reactions.

FDA Resubmission Follows January Complete Response Letter

Aquestive submitted the NDA resubmission on September 16, 2026, after receiving a Complete Response Letter (CRL) from the FDA on January 30, 2026. The company subsequently reported positive topline results from human factors and pharmacokinetic (PK) studies in August 2026, which addressed items raised in the regulatory letter.

Human factors studies assess whether patients and caregivers can use a medical product correctly, while PK studies examine how a drug is absorbed and becomes available in the body. These assessments are particularly relevant for emergency treatments, where administration errors or delays can affect patient outcomes.

The FDA’s Class 2 classification indicates that the resubmission is subject to a six-month review cycle under the agency’s Prescription Drug User Fee Act framework. The March 16, 2027, date represents the FDA’s target for regulatory action, not a guarantee of approval.

The company has not disclosed further details of the individual study results in this announcement. Consequently, the available information does not establish the magnitude of any improvements in usability or pharmacokinetic performance.

Sublingual Film Offers an Alternative Delivery Approach

Anaphylm is a polymer matrix-based sublingual film containing dibutepinephrine, an epinephrine prodrug. The film dissolves upon contact with moisture in the mouth and does not require water or swallowing for administration.

Its compact format distinguishes it from conventional epinephrine autoinjectors. According to the company, the film weighs less than an ounce and comes in packaging thinner and smaller than an average credit card, allowing it to be carried in a wallet or phone.

Anaphylaxis is a potentially life-threatening systemic allergic reaction that can progress rapidly and require immediate epinephrine treatment. Although injectable epinephrine remains the established first-line treatment, carrying and administering an injection can present practical challenges for some patients and caregivers.

Anaphylm’s sublingual delivery approach could expand the available administration options if clinical evidence and regulatory review support its use. However, its potential convenience does not establish equivalence to approved injectable products in clinical effectiveness, onset of action or safety. These considerations remain important in evaluating a treatment intended for anaphylaxis.

The FDA has conditionally approved the Anaphylm trade name, with final approval dependent on approval of the product itself.

Canadian Regulatory Submission Planned for Q4 2026

Aquestive is continuing preparations for a potential commercial launch in the United States while advancing its international regulatory strategy. The company expects to complete its New Drug Submission to Health Canada in the fourth quarter of 2026.

Chief Executive Officer Daniel Barber said the FDA’s acceptance provides a defined path toward the next regulatory decision. The company also plans to work with the agency throughout the review period.

Clinical and Regulatory Implications

The resubmission acceptance moves Anaphylm into another formal FDA review cycle, but the key question is whether the additional human factors and pharmacokinetic evidence adequately resolves the agency’s earlier concerns. The March 2027 decision will determine whether the sublingual formulation can enter the US market.

If approved, Anaphylm could introduce a new delivery option for people at risk of anaphylaxis. Its clinical value will depend on the FDA’s assessment of the complete evidence package, including whether the product can provide reliable drug delivery and practical usability during an emergency.

Reference

Aquestive Therapeutics Announces FDA Acceptance of Anaphylm™ NDA Resubmission and PDUFA Goal Date of March 16, 2027, Aquestive, 15 October 2026