Health Canada Approves neffy®--The First Needle-Free Epinephrine Spray for Anaphylaxis

TORONTO, April 15, 2026 /CNW/ - ALK-Abello Pharmaceuticals Inc. Canada (ALK Canada) today announced that Health Canada has approved neffy^® 2 mg for the emergency treatment of allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products and other allergens as well as idiopathic or exercise-induced anaphylaxis in adult and pediatric patients who weigh 30 kg or greater.¹

This approval addresses a critical need for Canadians affected by severe allergies that put them at risk of anaphylaxis. It is estimated that up to 2.5 million people in Canada are affected by severe allergies.^2,3 Research shows that half of those living with a life-threatening allergy do not consistently carry their prescribed epinephrine auto-injector and approximately half do not administer an auto-injector device when needed in an emergency.^4*

Dr. Anne Ellis, allergist and chair of the division of allergy and immunology at Queen's University said, "The gap between those who have severe allergies and are at risk for anaphylaxis, and those who actually carry self-administered epinephrine is a serious issue. Anaphylaxis can occur within minutes of exposure to allergens and rapid treatment with epinephrine is critical to treatment success. However, many patients and caregivers don't carry their epinephrine autoinjector or hesitate to use it, often due to needle fear and uncertainty about correct administration. A needle-free nasal spray that people can use confidently and easily may help improve how quickly and effectively people respond to an anaphylactic reaction."   

neffy^® is designed to fit into a pocket for portability.  It also has a 30-month shelf life from time of manufacture and can withstand temperature excursions up to 50°C, key differentiators from autoinjectors.^1,5 

neffy^® 2 mg was approved in Canada following clinical studies involving more than 700 participants. No serious side effects were reported.¹ The most frequently occurring adverse reactions (very common events ≥ 10%) observed in clinical studies of neffy^® were reported only after a second 2 mg dose (4 mg total) and include throat irritation (18.8%), headache (17.6%), nasal discomfort (12.9%) and feeling jittery (10.6%).¹

Andrew Desbarats, General Manager, ALK Canada, said: "The approval of neffy^® marks a significant step forward in the treatment of anaphylaxis in more than 35 years. For over a century, ALK has been dedicated to improving lives through allergy care, and with neffy®, we are providing a needle-free, portable epinephrine spray to help the approximately 2.5 million Canadians living with life-threatening allergies carry treatment wherever life takes them."

neffy^® is expected to be available in pharmacies across the country in summer 2026. In the interim, Canadians can register for notifications at www.neffy.ca. 

Clinical Evidence and Safety Profile

• neffy^® has an established safety profile¹; the clinical development program has generated more clinical data than any other epinephrine device: over 1100 administrations, dosed once or twice, in more than 700 participants.⁶
• clinical studies show that neffy^® is absorbed quickly through the nasal lining and delivers epinephrine consistently and predictably.^1,7
• neffy^® showed a similar response to autoinjectors across across a range of real-world scenarios including single and repeat doses, self-administration, use in children, and situations with nasal congestion from colds or allergies.^1,8

About neffy^® 

neffy^® 2 mg is a nasal spray designed to provide fast absorption of epinephrine.¹ neffy^® delivers a full, single dose of epinephrine in a user-friendly format, without the need for priming.^1,9 It has a 30-month shelf life and no special storage requirements.¹ Freezing does not affect its shelf life, however if it is accidentally frozen the nasal spray should be allowed to thaw for at least 1 hour before use, because it will not activate if frozen.¹ Beyond Canada, neffy^® is also approved in the United States and Japan, as well as the European Union and United Kingdom, where it is known as EURneffy^®.

About anaphylaxis

Anaphylaxis is a serious, potentially life-threatening allergic reaction.¹⁰ Symptoms generally include two or more body systems (e.g. skin, respiratory, gastrointestinal, cardiovascular.)¹⁰ Common triggers include foods (particularly peanuts, tree nuts, shellfish, milk, and eggs), insect stings, medications, latex and exercise.¹¹ Anaphylaxis is a medical emergency, and rapid recognition and management can be life-saving.¹⁰ Epinephrine is the only medication that reduces hospitalization and death and should be administered promptly following the onset of anaphylaxis.¹⁰             

About ALK Canada

For more than 100 years, ALK has been at the forefront of allergy research and treatment, with a global mission to help millions of people living with allergies. ALK Canada brings this legacy of innovation to Canadian patients and healthcare providers, offering a comprehensive portfolio of allergy therapies--from diagnostic testing to immunotherapy and emergency anaphylaxis care. For more information, visit www.alk.net/ca.

*based on a survey of adults (n = 450), parents of children (n = 255), and adolescents (n = 212) who had been prescribed an EAI in the US

References
^1	neffy^® Product Monograph. Available at: www.alk.net/ca/npm-en
^2	Health Canada. 2020: Research Related to the Prevalence of Food Allergies and Intolerances. Available online at: https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-allergies-intolerances/food-allergen-research-program/research-related-prevalence-food-allergies-intolerances.html. Accessed December 12, 2025.
^3	Statistics Canada. Canada's population estimates: Age and gender, July 1, 2025. Available online at: https://www150.statcan.gc.ca/n1/daily-quotidien/250924/dq250924a-eng.htm Accessed December 12, 2025
^4	Warren CM, et al. Ann Allergy Asthma Immunol. 2018;121:479–489.e2
^5	Lowenthal, et al. AAAAI 2024. Poster L32
^6	Data on file.
^7	Casale TB, et al. J Allergy Clin Immunol. 2023;152:1587-96
^8	Ellis AK, et al. Pharmaceutics. 2024;16:811
^9	Hernandez-Trujillo V, et al. ACAAI 2024. Poster 8066
^10	Government of Canada. Anaphylaxis and other acute reactions following vaccination: Canadian Immunization Guide. Available online at: https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-2-vaccine-safety/page-4-early-vaccine-reactions-including-anaphylaxis.html Accessed December 12, 2025.
^11	Food Allergy Canada. Food allergy FAQs. Available online at https://foodallergycanada.ca/food-allergy-basics/food-allergies-101/food-allergy-faqs/ Accessed December 12, 2025.

SOURCE ALK

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