Aquestive's Anaphylm Sublingual Film Achieves Study Goals and Advances Post-FDA Meeting

Aquestive Therapeutics, a pharmaceutical company that focuses on innovative delivery technologies for medicines, has announced positive results from its Phase 3 clinical study of Anaphylm™, a sublingual film containing epinephrine. The study demonstrated that Anaphylm meets all primary and secondary pharmacokinetic endpoints, showing faster time to maximum concentration (Tmax) than autoinjectors and comparable exposure levels (AUC) for 30 minutes post-dosing. The product was also well-tolerated with no serious adverse events reported.

The company's President and CEO, Daniel Barber, expressed satisfaction with the study outcomes and the FDA's positive feedback. He highlighted the importance of rapid absorption of epinephrine in treating severe allergic reactions and anaphylaxis, noting that Anaphylm's performance is unprecedented among alternate delivery options.

Dr. David Golden, an anaphylaxis expert, emphasized the potential of Anaphylm as a needle-free alternative to current treatments, offering a convenient and easily administered life-saving medication.

The Phase 3 study involved a comparison of Anaphylm's pharmacokinetics and pharmacodynamics against intramuscular injections and autoinjectors in healthy adults. Key findings from the single dosing part showed Anaphylm achieved a geometric mean Cmax within the range of autoinjectors, maintained partial AUCs between autoinjectors and manual IM injection from 5 to 60 minutes, and had a median Tmax of 12 minutes, significantly faster than EpiPen, AUVI-Q, and Adrenalin.

In the repeat dosing part, Anaphylm maintained plasma concentrations equal to or greater than existing injection products, with a median Tmax of 10 minutes after the second dose and consistent pharmacodynamics.

A Type C meeting with the FDA addressed concerns from the previous End-of-Phase 2 meeting, and the FDA indicated that the company has "adequately addressed" previous concerns. The FDA recommended administering Anaphylm after oral exposure to allergens and assessing PK performance, a study planned for the second quarter of 2024.

Aquestive Therapeutics is committed to advancing Anaphylm as a novel treatment for severe allergic reactions and aims to file a New Drug Application (NDA) with the FDA before the end of 2024. The company's PharmFilm® technology offers a promising platform for orally administered complex molecules, providing alternatives to traditional therapies.

Anaphylaxis is a serious and potentially fatal allergic reaction affecting millions in the U.S., with hospital admissions for the condition increasing significantly in recent years. Epinephrine injection is the current standard treatment, and Anaphylm's development could offer a new option for those at risk.

Aquestive Therapeutics is dedicated to improving patient lives through innovative pharmaceuticals and has a pipeline focused on central nervous system diseases and severe allergic reactions. The company's commitment to drug development and commercialization is evident through its collaborations and manufacturing partnerships.