• 21 Jul 2025
• Admin
• News Article

EURneffy gets UK approval as the First and Only Needle-Free Emergency Treatment of Allergic Reactions

Overview

ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect themselves from allergic reactions that could lead to anaphylaxis, announced today that the United Kingdom (U.K.) Medicines and Healthcare Products Regulatory Agency (MHRA) has granted approval for EURneffy (adrenaline nasal spray) for the emergency treatment of allergic reactions (anaphylaxis) in adults and children who weigh greater than 30 kg.

Statement from Richard Lowenthal: President and CEO of ARS Pharma

“The approval of EURneffy marks a major milestone as the first needle-free adrenaline treatment available in the U.K. for adults and children with severe allergies. This innovation addresses a critical need for the many patients who may not carry, or hesitate to use, an injectable option in an emergency,” said Richard Lowenthal, Co-founder, President and CEO of ARS Pharma. 
“The innovative design of EURneffy with its small size, temperature stability up to 50°C and longer shelf life compared to auto-injectors, encourages patients and caregivers to always carry and use epinephrine at the first sign of symptoms related to a food or venom allergy reaction. We are pleased to receive this approval and expand availability of our epinephrine nasal spray as part of our partnership with ALK-Abelló A/S.”

ARS Pharma Grants ALK Rights to Neffy Outside U.S. in $145M Deal

• In November 2024, ARS Pharma entered into an exclusive licensing agreement with ALK-Abelló A/S (Nasdaq: ALK B), granting ALK the rights to commercialize neffy (epinephrine nasal spray) outside the United States, including Europe (where it is marketed as EURneffy), Canada, and select other international markets. 
• ARS Pharma retains full commercial rights to neffy in the U.S., with no changes to its existing partnerships in Japan, China, Australia, and New Zealand. 

Terms of the agreement

Under the terms of the agreement, ARS Pharma received a $145 million upfront payment in 2024 and is eligible for up to an additional $320 million in regulatory and commercial milestone payments, in addition to tiered double-digit royalties in the teens on net sales in the licensed territories.

Neffy Launches in U.S. for Allergic Reactions; ARS and ALK Begin Co-Promotion

In late June, ALK successfully launched EURneffy in Germany. Regulatory approvals for neffy in Canada (with ALK), Japan (in partnership with Alfresa), and Australia (in partnership with CSL), are expected by the end of 2025, with commercial rollouts planned for early 2026. As well, regulatory approval for neffy in China (in partnership with Pediatrix) is expected in 2026.
EURneffy is the trade name for neffy® (epinephrine nasal spray) in the United Kingdom.

About neffy®

• neffy is a nasal spray used for emergency treatment of allergic reactions including anaphylaxis, in adults and children aged 4 years and older who weigh 33 lbs. or greater.
• INDICATION AND IMPORTANT SAFETY INFORMATION FOR neffy (epinephrine nasal spray)

Indication

• Neffy is indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients aged 4 years and older who weigh 33 lbs. or greater.

Important safety information

• Neffy contains epinephrine, a medicine used to treat allergic emergencies (anaphylaxis). Anaphylaxis can be life-threatening, can happen in minutes, and can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or other unknown causes.
• Always carry two neffy nasal sprays with you because you may not know when anaphylaxis may happen and because you may need a second dose of neffy if symptoms continue or come back. Each neffy contains a single dose of epinephrine. neffy is for use in the nose only.
• Use neffy right away, as soon as you notice symptoms of an allergic reaction. If symptoms continue or get worse after the first dose of neffy, a second dose is needed. If needed, administer a second dose using a new neffy in the same nostril starting 5 minutes after the first dose. Get emergency medical help for further treatment of the allergic emergency (anaphylaxis), if needed after using neffy.
• Tell your healthcare provider if you have underlying structural or anatomical nasal conditions, about all the medicines you take, and about all your medical conditions, especially if you have heart problems, kidney problems, low potassium in your blood, Parkinson's disease, thyroid problems, high blood pressure, diabetes, are pregnant or plan to become pregnant, or plan to breastfeed.
• Tell your healthcare provider if you take or use other nasal sprays or water pills (diuretics) or if you take medicines to treat depression, abnormal heart beats, Parkinson's disease, heart disease, thyroid disease, medicines used in labor, and medicines to treat allergies. neffy and other medications may affect each other, causing side effects. neffy may affect the way other medicines work, and other medicines may affect how neffy works.
• Serious side effects

Neffy may cause serious side effects. If you have certain medical conditions or take certain medicines, your condition may get worse, or you may have more or longer lasting side effects when you use neffy.

• Common side effects

Common side effects of neffy include: nasal discomfort, headache, throat irritation, chest and nasal congestion, feeling overly excited, nervous or anxious, nose bleed, nose pain, sneezing, runny nose, dry nose or throat, tingling sensation, including in the nose, feeling tired, dizziness, nausea, and vomiting.

• Tell your healthcare provider if you have any side effects that bother you or that do not go away after using neffy.