Aquestive Therapeutics receives an FDA Complete Response Letter for Anaphylm™, a novel sublingual epinephrine film for anaphylaxis, as the FDA review continues ahead of the January 2026 PDUFA date.
Written By: Nikita Chudhari, BPharm
Reviewed By: Pharmacally Editorial Team
Aquestive Therapeutics, Inc. has announced that it has received a Complete Response Letter related to the New Drug Application for Anaphylm™, its investigational sublingual epinephrine film for the treatment of severe allergic reactions, including anaphylaxis.
According to the company, the U.S. Food and Drug Administration identified deficiencies in the NDA that currently prevent discussions on labeling and post-marketing commitments. The FDA clarified that this notification does not represent a final regulatory decision, and the agency’s review of the application is still ongoing.
Dan Barber, President and Chief Executive Officer of Aquestive, stated that while the FDA has not yet specified the deficiencies, the company is actively engaging with the agency to understand and address the concerns as quickly as possible.
Confidence in Anaphylm and Strategic Outlook
Despite the regulatory setback, Aquestive reiterated its confidence in Anaphylm and its potential to become the first and only FDA-approved sublingual epinephrine product. The company highlighted Anaphylm’s design as easy to use, fast acting, and highly portable, features that could address important limitations associated with injectable epinephrine devices.
The company also confirmed that its broader business strategy remains intact. With a recent equity raise and a solid cash position, management believes it has sufficient capital to continue executing its regulatory, commercial, and global expansion plans.
NDA Status and Clinical Development Program
Anaphylm’s NDA is currently under active review, with a PDUFA action date of January 31, 2026. The FDA has indicated that it will not issue a Discipline Review Letter, although additional information requests may occur during the remaining review period. Delays in clarifying the identified deficiencies could potentially impact the approval timeline.
The NDA submission is supported by an extensive clinical development program that includes eleven independent clinical studies. Across these studies, Anaphylm was administered approximately 967 times in 411 subjects, which includes 840 single-dose and 127 repeat-dose administration of Anaphylm.
The program also included a first-of-its-kind oral allergy syndrome study designed to evaluate Anaphylm in a real-world, allergen-triggered setting. Pharmacokinetic data demonstrated that Anaphylm delivers epinephrine exposure comparable to leading epinephrine auto-injectors. Overall, the product was generally well tolerated, with a safety profile consistent with that of epinephrine.
Global Regulatory Expansion Plans
Alongside its U.S. regulatory efforts, Aquestive continues to advance Anaphylm’s global development strategy. Regulatory engagements have already been initiated in Canada, Europe, and the United Kingdom.
The company plans to submit a New Drug Submission to Health Canada in the first half of 2026. In Europe, the European Medicines Agency has provided positive feedback indicating that no additional clinical trials are required prior to submission, with a marketing authorization application expected in the second half of 2026. In the United Kingdom, feedback from the Medicines and Healthcare products Regulatory Agency is anticipated in the first quarter of 2026.
These regions represent key opportunities to expand global access to a non-invasive epinephrine therapy.
Commercial Readiness and U.S. Launch Plans
If approved by the FDA, Aquestive plans to hire its U.S. sales force and complete remaining pre-commercial activities for Anaphylm. The company emphasized its focus on addressing critical unmet needs in severe allergy management and bringing an orally delivered epinephrine option to patients who may face challenges with injectable therapies.
Financial Position
As of the end of 2025, Aquestive reported approximately $120 million in cash and cash equivalents. The company believes this level of funding is sufficient to support the completion of the U.S. approval process, a potential commercial launch, and continued progress in key international markets.
About Anaphylm™
Anaphylm™ (dibutepinephrine) Sublingual Film is a polymer matrix-based epinephrine prodrug designed for oral administration. The film is similar in size to a postage stamp, dissolves on contact without the need for water or swallowing, and is packaged in a compact, weather-resistant format that can easily fit in a pocket.
The proprietary name Anaphylm, previously known as AQST-109, has received conditional approval from the FDA. Final approval of the trade name is contingent upon regulatory approval of the product itself.
If approved, Anaphylm could represent a meaningful advancement in the emergency treatment of anaphylaxis by offering the first orally delivered epinephrine therapy.
References
Aquestive Therapeutics Announces Regulatory Development for Anaphylm™ (dibutepinephrine) Sublingual Film and Provides Business Update, 09 January 2026, https://investors.aquestive.com/news-releases/news-release-details/aquestive-therapeutics-announces-regulatory-development