Imagine swapping a bulky, intimidating auto-injector needle for a tiny strip you pull out of your wallet that dissolves right under your tongue—and actually works faster. That’s the promise of Anaphylm, an oral epinephrine film being developed by Aquestive Therapeutics, and it just cleared a massive hurdle on its way to your pharmacy.
Earlier this year, the FDA put the brakes on Anaphylm’s approval over a frustratingly simple problem: the packaging. People in clinical trials were struggling to open the foil pouch and figure out where the film was supposed to go. When every second counts during a severe allergic reaction, a stubborn wrapper is a dealbreaker.
Aquestive went back to the drawing board, redesigned the packaging and instructions, and just released the new data. The fix worked—and the pharmacokinetic (PK) results show it packs a punch:
- Lightning-Fast Access: Redesigning the tear pouch slashed the median time to open it from 17 seconds down to just 3 seconds.
- Fewer User Errors: Out of 105 participants testing the new design, only one person had trouble opening it (down from 26 in the previous trial), and placement errors dropped dramatically. No one chewed it or spat it out early.
- Beating the Needle on Speed and Concentration: In head-to-head clinical PK testing, self-administered Anaphylm reached peak epinephrine levels (Cmax) of 391.7 pg/mL in just 12 minutes (Tmax)—matching clinician-administered film (357.6 pg/mL at 12 minutes). By contrast, a traditional manual epinephrine injection took 45 minutes to hit a lower peak of 334.5 pg/mL.
The FDA also asked Aquestive to test what happens if a panicked patient accidentally sticks the strip on top of their tongue or the roof of their mouth instead of underneath it. The PK data revealed that top-of-tongue placement took longer (Tmax of 35 minutes), but still hit a peak concentration above 100 pg/mL. This was enough to trigger a strong, life-saving spike in blood pressure—performing comparably to a traditional injection.
Said Aquestive’s President and CEO Dan Barber: “Our Anaphylm program has reached an important milestone. The topline results from our human factors and pharmacokinetic studies reinforce our confidence in the revised packaging design and instructions for use as we prepare for our planned NDA resubmission. If approved, we believe Anaphylm has the potential to be the first and only non-invasive, orally delivered epinephrine product for patients at risk of life-threatening allergic reactions. We are grateful to the patients, participants, caregivers, and investigators who participated in these studies, as we plan to resubmit our NDA less than eight months from receipt of a Complete Response Letter from the FDA.”
With no serious side effects reported and the packaging headaches resolved, Aquestive plans to resubmit its application to the FDA by the fall of 2026. If approved, Anaphylm could officially become the world’s first non-invasive, needle-free epinephrine strip for life-threatening allergies.
