The Food and Drug Administration has accepted Aquestive Therapeutics’ new drug application for an oral epinephrine film to treat severe allergic reactions. Called Anaphlym, the film adheres to the membrane beneath the tongue and dissolves rapidly without water.
FDA acceptance of a new drug application is a significant step in the drug approval process. Companies submit an application after they have completed the clinical trials that they believe are needed for approval. The federal agency told Aquestive that it will make a decision epinephrine product by January 31, 2026.
“We are incredibly excited,” Daniel Barber, Aquestive’s president and CEO, tells Allergic Living. If approved, Anaphylm “is going to save lives. People will have an epinephrine product with them who would otherwise not, and people who would have otherwise waited will take it sooner. Both of those scenarios will improve outcomes,” he says.
Roughly the size of a postage stamp, Anaphylm can be slipped into a wallet, pocket or phone case. Each packet contains a 12-milligram (mg) dose and would be for adults and children weighing at least 66 pounds.
Allergist Dr. David Stukus, director of the food allergy center at Nationwide Children’s Hospital, said an oral film option that’s convenient to carry and needle-free may mean more timely epinephrine use.
“While epinephrine remains the only FDA-approved first-line treatment, too many at-risk individuals don’t carry it consistently or hesitate to use it when seconds count,” Stukus says. “An oral, no-needle approach could be transformative for anaphylaxis care.”
Oral Epinephrine Film’s Speed Touted
A pivotal Phase 3 clinical trial of the dissolving film included 64 adults. It showed that the median time for Anaphylm to reach peak concentration of epinephrine in the blood was 12 minutes. That was faster than the EpiPen at 20 minutes, AUVI-Q auto-injector at 30 minutes, and epinephrine given by syringe at 50 minutes.
“We clearly are faster,” says Dr. Carl Kraus, Aquestive’s chief medical officer. “It is a rescue therapy, and the speed is a huge benefit to patients. Being able to put this under your tongue and achieve that level in a few minutes is wonderful for patients.”
Initial findings of a pediatric trial in 32 children ages 7 to 17 showed comparable results.
In an additional study requested by the FDA, the oral epinephrine film worked well in patients experiencing mouth swelling due to oral allergy syndrome. The condition causes localized itching and swelling in the mouth and throat after eating certain raw fruits or vegetables such as apples or kiwi.
The FDA wanted to make sure oral symptoms, which also occur during anaphylaxis, don’t interfere with epinephrine absorption. The oral allergy study results showed swelling started to ease two minutes after receiving Anaphylm. The average time to complete symptom resolution was 12 minutes.
Next Steps for Oral Epinephrine Film
If approved, Anaphylm would become the second needle-free alternative to epinephrine auto-injectors in the U.S.
The first to become available to consumers is ARS Pharmaceuticals’ neffy epinephrine nasal spray. In August 2024, the FDA approved a 2 mg neffy dose for adults and kids weighing at least 66 pounds. Then in March 2025, a 1 mg neffy dose was approved for children 4 years and older and weighing 30 to 66 pounds.
Before its final decision on the oral film, the FDA may convene an independent advisory committee of experts to review the company’s data. ARS Pharma went through this review process with neffy. If such a meeting were to be held, Barber says it would likely be in the fall.
The CEO says he would welcome it. FDA advisory committee meetings are open to the public, and include representatives from the allergy community, including patients and advocacy groups. “It would be a really good opportunity for us to tell our story and make sure we tell the world about our data,” he says.
Families are asked to submit comments on what epinephrine products would make their lives easier. “It’s clear what patients want. They want choice,” says Barber. “They want products they can carry without disrupting their daily lives. And they want products that work in every scenario they could possibly be in.”
Aquestive’s research shows that its oral epinephrine film holds up under extreme conditions. This includes long periods in high heat, when frozen or after being submerged in water.
In an extreme heat test, with similar to conditions in a hot car, the film retained 97 percent of its potency after one week.
When Will Anaphylm Hit Pharmacy Shelves?
If it gets the green light, Anaphylm could become available to patients within weeks of FDA approval, Barber says. However, insurance coverage and widespread awareness from physicians will take longer.
After approval, Aquestive will conduct outreach to raise awareness among families and providers. The company will also shift focus to developing a lower dose for smaller children 30 to 66 pounds.
Related Reading:
Neffy Epi Data: Real-World Feedback and Congestion Studies
Ants With Sting That Triggers Anaphylaxis Spread in the U.S.
