Anaphylm sublingual film demonstrates positive results in pediatric patients with severe allergic reactions

Anaphylm (Photo courtesy of Aquestive Therapeutics.)

On April 1, 2025, Aquestive Therapeutics announced positive topline results from its pediatric study evaluating Anaphylm (epinephrine) sublingual film in patients aged 7 to 17 years.¹

The study included children weighing more than 30 kilograms with a history of allergic reactions. These results mark the completion of the Anaphylm clinical program and support the company’s New Drug Application (NDA) submission to the FDA.^1,2

“We are extremely pleased with the positive results from our pediatric study, which further validate Anaphylm's potential as the first-ever sublingual film and convenient treatment option for all patients with severe allergic reactions, including anaphylaxis,” said Daniel Barber, president and CEO of Aquestive.

Anaphylm is a polymer matrix-based epinephrine prodrug candidate designed for the treatment of severe allergic reactions, including anaphylaxis.

It is similar in size to a postage stamp, weighs less than an ounce, and begins to dissolve upon contact without the need for water or swallowing. The packaging is compact, smaller than a credit card, and designed to withstand environmental factors like rain and sunlight, according to the company.

The multi-site, single-treatment study evaluated the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of Anaphylm.

A total of 32 patients completed the study. The PK results were consistent with previous adult studies. Additionally, Anaphylm was well-tolerated, with no serious adverse events reported.

“These results demonstrate that Anaphylm maintains its consistent PK profile in pediatric patients between the ages of seven and seventeen and weighing greater than thirty kilograms,” Barber stated.

He added, “These data are an important component of the FDA review process and could enable Anaphylm to have a label that includes this pediatric patient population. We continue to prepare for commercial readiness and plan to launch Anaphylm in the first quarter of 2026, if approved by the FDA.”

Aquestive has submitted the Anaphylm NDA to the FDA and anticipates potential acceptance during the second quarter of 2025.

References:

1. Aquestive Therapeutics. Aquestive Therapeutics Announces Positive Topline PK Results from its Pediatric Study and Completes the NDA Submission for Anaphylm™ (epinephrine) Sublingual Film. Global Newswire. April 1, 2025. Accessed April 1, 2025. https://www.globenewswire.com/news-release/2025/04/01/3053173/0/en/Aquestive-Therapeutics-Announces-Positive-Topline-PK-Results-from-its-Pediatric-Study-and-Completes-the-NDA-Submission-for-Anaphylm-epinephrine-Sublingual-Film.html

2. Aquestive Therapeutics. Aquestive Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update. Aquestive.com. April 1, 2025. Accessed April 1, 2025. https://investors.aquestive.com/news-releases/news-release-details/aquestive-therapeutics-reports-fourth-quarter-and-full-year-2024