New adrenaline patch for allergic reactions moves closer to approval in America 

The United States (US) Food & Drug Administration (FDA) has accepted Aquestive Therapeutics’ New Drug Application (NDA) for Anaphylm™ – a postage stamp–sized film that delivers adrenaline under-the-tongue during serious allergic reactions. The acceptance follows strong clinical trial results in both children and adults. 

What is Anaphylm™ ? 

Anaphylm is a medicine being developed by Aquestive Therapeutics for the emergency treatment of serious allergic reactions, including anaphylaxis. It is a small, fast-dissolving film, roughly the size of a postage stamp, that is placed under the tongue. Once there, it quickly releases adrenaline (the same medication used in adrenaline auto-injectors like EpiPen and Jext) to help reverse the symptoms of a serious allergic reaction. 

Because of its small size, the film comes in compact packaging that makes it easy to carry – fitting in a wallet or pocket. The packaging is also designed to withstand exposure to extreme temperatures, rain, and sunlight. 

What does FDA acceptance of the NDA mean? 

The FDA is the agency in the US responsible for deciding if new medicines are safe and effective. When a company believes it has enough evidence that a medicine works, it submits a detailed report called a New Drug Application (NDA). The FDA has now accepted the application to review Anaphylm.  

While this doesn’t mean the medicine is approved yet, it is an important step. The FDA will carefully examine all the clinical trial data and is expected to make a decision by January 31, 2026, on whether Anaphylm can be sold in the US, or if more testing is needed. 

The evidence behind Anaphylm 

The application for Anaphylm is supported by promising results from clinical trials and tests that looked at how it performs in real-life situations. Aquestive Therapeutics shared this data at recent allergy conferences, including the CFAAR Food Allergy Summit in Chicago. Key findings included: 

• Anaphylm delivered adrenaline into the bloodstream quickly, reaching its highest level in the body in around 12 minutes.  

• It worked just as well in children (aged 7–17) as it did in adults. 

• No serious side effects were reported during the trials. 

• Allergy symptoms improved significantly more quickly when Anaphylm was used compared to no treatment. 

• It was still effective even when there was swelling in the mouth, which can sometimes happen during a serious allergic reaction. 

• The film stayed effective even after exposure to extreme temperatures, water, folding, or accidental washing. 

These results suggest reliability of Anaphylm in real-world emergencies, even if it hasn’t been stored perfectly.  

What happens next? 

Right now, Anaphylm is not available in the US or the UK. The FDA is reviewing the data and will decide by early 2026 whether it can be approved for use. 

If approved, Anaphylm could become the second needle-free adrenaline option available in the US. The first was a nasal spray, neffy®, which received approval in the US earlier this year. However, neffy has not yet been approved for use in the UK. 

Approval of Anaphylm in the UK would require a separate process through the UK’s medicines regulator (the MHRA), so it may take more time before Anaphylm is considered here. 

Anaphylm could one day offer a simpler and less intimidating option for treating serious allergic reactions – especially for people who are afraid of needles. But for now, people should continue carrying their prescribed adrenaline auto-injectors and follow their allergy action plans. 

View the press release here.