FDA, Duke University Planning Epinephrine Access Workshop for December

FDA will convene a one-day, in-person and virtual public workshop, “Improving Anaphylaxis Outcomes: Approaches for Enhancing Access to Epinephrine,” on Tuesday, Dec. 16, 2025 (1). The workshop is being held in conjunction with Duke University’s Margolis Institute for Public Policy.

An announcement of the workshop outlined its purpose: to jump-start the discussion about expanding the accessibility to, and use of, epinephrine to reduce morbidity and mortality related to anaphylaxis, including in community settings (1).

“Despite epinephrine's critical role in preventing anaphylactic deaths, potential barriers limit access to and use of this life-saving medication,” the announcement said (1). “Patients prescribed epinephrine may not have it available during anaphylaxis, may choose not to use it due to knowledge gaps, fear, stigma, misperceptions, or discomfort, or may use it incorrectly, resulting in inadequate dosing.”

What are the recent innovations in targeting anaphylaxis?

In the last 18 months, regulatory bodies have expanded access to potentially life-saving epinephrine treatments, particularly in a nasal spray formulation developed by San Diego-based ARS Pharmaceuticals.

ARS’ product, known as Neffy in the United States and commercialized outside the US, Australia, New Zealand, Japan, and China by ALK as EURneffy, was recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use in June 2024, approved by FDA in August 2024, and approved by the United Kingdom’s Medicines and Healthcare products Regulatory Agency in July 2025 (2–4).

ALK later announced, on Oct. 20, 2025, that EURneffy would be made available for prescription by healthcare professionals in the UK (5).

How will this help those who experience type 1 allergic reactions?

At the time of the August 2024 FDA approval, Richard Lowenthal, ARS Pharmaceuticals co-founder, president, and CEO, commented on the potential impact of the availability of an anaphylactic in nasal spray form.

“This approval marks a watershed moment in addressing an unmet medical need for people with type 1 allergies—a treatment alternative that avoids the need to inject epinephrine with a needle, which can be fraught with anxiety and fear for many,” Lowenthal said (3).

Following the October 2025 UK approval of prescription EURneffy use, Amena Warner, Head of Clinical Services at Allergy UK, echoed the same theme.

“Some young people have been reluctant to carry auto-injector devices because they find them bulky,” Warner said (5). “This is concerning for healthcare professionals and parents alike, as it increases the risk of a delay in potentially life-saving treatment.”

How can people participate in the workshop?

Comments from the public, submitted either in electronic or written form, are being accepted up to one month following the workshop, through Jan. 16, 2026 (1). The online submission form is available through the Federal Register website. The request period to make oral presentations at the workshop closed on Nov. 21; participants will be selected and notified by Dec. 1, and all presentation materials must be submitted by Dec. 11.

The in-person component of the workshop will be held at the Duke in DC Office, 1201 Pennsylvania Ave. NW, Suite 500, Washington, DC, from 9:00 a.m. to 4:30 p.m. on Dec. 16, 2025 (1).

References

1. FDA, “Improving Anaphylaxis Outcomes: Approaches for Enhancing Access to Epinephrine,” Notice of Public Workshop—Request for Comments, Federal Register, 90 FR 52958, 52958–52960.
2. EMA. First Nasal Adrenaline Spray for Emergency Treatment Against Allergic Reactions. Press Release. June 28, 2024.
3. FDA. FDA Approves First Nasal Spray for Treatment of Anaphylaxis. Press Release. Aug. 9, 2024.
4. ALK. EURneffy Approved as the First Needle-Free Anaphylaxis Treatment of Adults and Children in the UK. Press Release. July 18, 2025.
5. Allergy UK. Allergy UK Welcomes Needle-Free Emergency Adrenaline Treatment for Anaphylaxis. Press Release. Oct. 20, 2025.