Anaphylm Sublingual Film Achieves Rapid Resolution of Allergen-Related Symptoms

Anaphylm (epinephrine) sublingual film achieved key primary and secondary endpoints for resolving symptoms of severe allergic reactions, such as anaphylaxis, based on positive topline results from the Oral Allergy Syndrome (OAS) challenge study.¹

Announced by Aquestive Therapeutics on October 24, 2024, the rapid resolution of allergen-related symptoms began 2 minutes after administration of Anaphylm, with a comparable pharmacokinetic (PK) profile after allergen exposure to a non-allergen profile.

“I am reassured by the speed of symptom relief seen in the OAS study and by the continued and consistent rapid absorption profile of Anaphylm,” said Jay Lieberman, MD, a professor of medicine in the department of pediatrics at the University of Tennessee Health Science Center. “These data provide strong evidence that Anaphylm could provide a reliable alternative to the approved epinephrine medical devices currently available to patients.”

A polymer matrix-based epinephrine prodrug product candidate, Anaphylm begins to dissolve on contact and requires no water or swallowing for administration.² The OAS challenge study was created in two parts to assess the PK and pharmacodynamic (PD) profile of Anaphylm in adults with allergen-induced oral physiological change.¹

The first part of the study enrolled patients with confirmed OAS into a 3-period study in 3 arms: Anaphylm with allergen exposure (n = 18 single dose; n = 18 repeat dose), Anaphylm without allergen exposure (n = 15 single dose; n = 13 repeat dose), and Adrenalin intramuscular (IM) injection without allergen exposure (n = 18 single dose; n = 17 repeat dose).

An optional follow-up study switched 6 patients who received a single dose and 6 subjects who received a repeat dose of Anaphylm in Part 1 to the opposite dose. Anaphylm was administered with an allergen exposure, with resulting symptoms categorized for location, severity, and duration, while IM was administered without an allergen exposure.

After exposure to the allergen, all participants reported consistent symptoms with their known allergy experience, including 25% reporting swelling of the tongue, lips, cheeks, or throat. Approximately 94% of participants were categorized as having moderate or severe symptoms on the pre-defined oral severity score.

Complete symptom resolution after administration of Anaphylm was achieved in 12 minutes, notably faster than the 74 minutes needed for complete symptom resolution at screening. After administration, symptoms were resolved in as early as 2 minutes in some patients, with 50% experiencing resolved symptoms by 5 minutes. All instances of swelling were resolved completely by the 5-minute mark with Anaphylm.

Primary and secondary endpoints of the OAS challenge study were successfully met, finding no significant differences between Anaphylm PK results in those with and without allergen exposure. According to Aquestive, the PK profile remained similar to the company’s pivotal study in healthy subjects.

Further data showed the time to maximum plasma concentration (Tmax) remained at 12 minutes in participants with and without allergen exposure after a single Anaphylm dose, with a comparable maximum plasma concentration (Cmax). Anaphylm remained safe and tolerable—all adverse events were categorized as mild or moderate.

Aquestive has announced its request for a pre-New Drug Application (NDA) meeting with the FDA, with expectations to meet in Q4 2024. The company remains on track to conduct a pediatric study in children weighing ≥30 kgs in Q4 2024 and submit the NDA in Q1 2025.

Pending regulatory approval, Aquestive will initiate the full product launch of Anaphylm in Q1 2026.

“We are extremely pleased with the positive results from our OAS challenge study, which further validates Anaphylm’s potential as a game-changing treatment option for severe allergic reactions,” said Daniel Barber, president and chief executive officer of Aquestive. “These results demonstrate that Anaphylm maintains its consistent PK and PD profile even when administered during oral allergic conditions, such as swelling.”

References

1. _{Aquestive Therapeutics announces positive topline results from Oral Allergy Syndrome (OAS) Challenge Study for AnaphylmTM (epinephrine) sublingual film. Aquestive Therapeutics. October 24, 2024. Accessed October 24, 2024. https://investors.aquestive.com/news-releases/news-release-details/aquestive-therapeutics-announces-positive-topline-results-oral.}
2. _{ANAPHYLMTM. Aquestive. Accessed October 24, 2024. https://aquestive.com/anaphylm/.}