The End of the EpiPen Era? Aquestive's Oral Film Promises a Revolution in Anaphylaxis Care

WARREN, NJ – February 20, 2026 – For decades, the emergency treatment of severe allergic reactions has been synonymous with the jab of an auto-injector. But a New Jersey-based pharmaceutical company is poised to challenge that paradigm with a product that could fundamentally alter the landscape of anaphylaxis care. Aquestive Therapeutics announced today that it will present new clinical data on its postage-stamp-sized oral film, Anaphylm™, at the upcoming American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting. The data suggests the product can not only effectively deliver life-saving epinephrine but may do so with a more stable safety profile than existing treatments.

A New Frontier in Patient-Centric Design

Anaphylm™ (dibutepinephrine) is not a needle or a spray, but a sublingual film. Designed to be placed under the tongue, it dissolves on contact without the need for water, rapidly delivering a prodrug that the body converts into epinephrine. This innovative delivery system directly addresses some of the most significant barriers that have plagued anaphylaxis treatment for years.

The product's design focuses on convenience and discretion. Weighing less than an ounce and housed in packaging thinner than a credit card, it can be easily carried in a wallet or phone case, a stark contrast to the bulky auto-injectors patients are often reluctant to carry. This portability is designed to combat the well-documented problem of patients not having their epinephrine on hand when a life-threatening reaction occurs.

“These results build on our work to date, which is substantial and underscores Anaphylm’s potential to deliver clinically meaningful outcomes while offering an easy-to-carry alternative to injectable epinephrine,” said Daniel Barber, President and Chief Executive Officer of Aquestive, in a statement. “Designed to address the practical and psychological barriers that have prevented consistent epinephrine carriage and use for decades, Anaphylm has the potential to transform anaphylaxis management.”

The Science of a Safer Rescue

Beyond convenience, Aquestive is highlighting a key clinical differentiator. The data to be presented at the AAAAI meeting, held from February 27 to March 2 in Philadelphia, shows that Anaphylm™ achieves clinically relevant epinephrine plasma concentrations without causing a dip in diastolic blood pressure. While epinephrine is essential for reversing the life-threatening symptoms of anaphylaxis—such as plummeting blood pressure and airway constriction—its administration can cause cardiovascular side effects, including spikes in blood pressure and heart rate.

“A dip in diastolic blood pressure after treating anaphylaxis with epinephrine is a serious clinical concern,” noted Matthew Greenhawt, MD, MBA, MSc, the lead author of one of the poster presentations. “Our data show no diastolic blood pressure dip following sublingual administration of Anaphylm – a clinically notable finding that advances our understanding of sublingually delivered epinephrine’s impact on hemodynamic response when treating anaphylaxis.”

This finding suggests a potentially smoother and safer hemodynamic profile, which could be particularly important for patients with underlying cardiovascular conditions. If Anaphylm is proven to provide the life-saving benefits of epinephrine with fewer unsettling side effects, it could offer significant peace of mind to both patients and prescribing physicians.

Navigating the Path to Market

While the clinical news is promising, Aquestive’s path to market has not been without challenges. The company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on January 30, 2026. A CRL indicates that the agency has completed its review of a new drug application but cannot approve it in its present form.

Crucially, the FDA’s concerns were not related to the drug's safety, efficacy, or manufacturing. Instead, the deficiencies cited were focused on the “human factors” validation study. The agency noted issues with users having difficulty opening the pouch and correctly placing the film, alongside concerns that some might inadvertently chew the film instead of letting it dissolve. In response, Aquestive has already modified the packaging, labeling, and instructions for use. The company plans to conduct a new human factors study and aims to resubmit its application as early as the third quarter of 2026, potentially pushing a U.S. launch into 2027.

Despite the delay, the nature of the CRL is seen by many industry observers as a positive sign, suggesting the core science behind Anaphylm™ is sound. Aquestive is also pursuing approvals globally, with submissions planned for Canada and Europe in 2026.

Reshaping a Multi-Billion Dollar Market

The market for anaphylaxis treatment is substantial, valued at approximately $3.45 billion in 2025 and projected to grow significantly due to the rising prevalence of severe allergies. For years, this market has been dominated by auto-injectors like the EpiPen, a brand that became a household name for both its life-saving utility and its controversial price hikes.

Patient adherence with auto-injectors is notoriously poor, hindered by needle phobia, high costs, and the inconvenience of carrying the bulky devices. Anaphylm™ is positioned to disrupt this status quo by directly addressing these pain points. However, it won't be the only needle-free option on the block. ARS Pharmaceuticals recently gained FDA approval for Neffy, a nasal spray epinephrine, giving it a significant head start in capturing the non-injectable market share. The race is on to see which alternative delivery method will win the trust of patients, physicians, and payers.

Should Anaphylm™ gain approval, it would be the first and only oral medication for the rescue treatment of anaphylaxis, a distinction that Aquestive is banking on. The company's broader AdrenaVerse™ platform, a library of over 20 epinephrine prodrugs, signals a long-term commitment to innovating in the allergy space. With a cash runway projected to last into 2027 and strategic financing contingent on FDA approval, Aquestive appears prepared for the final leg of its regulatory journey and a potential commercial showdown that could redefine emergency allergy care for millions.