Health Canada Approves Neffy for Needle-Free Anaphylaxis Treatment
neffy has been approved in Canada as a needle-free epinephrine nasal spray for the emergency treatment of anaphylaxis, ALK-Abello Pharmaceuticals Inc. Canada announced in Toronto on April 15, 2026 ET. Health Canada authorized neffy 2 mg for adult and pediatric patients who weigh 30 kg or greater, covering reactions tied to insect stings or bites, foods, medicinal products and other allergens, as well as idiopathic or exercise-induced anaphylaxis. the product is expected to reach pharmacies across the country in summer 2026.
Health Canada approval puts neffy in line for summer 2026 rollout
The approval comes amid concern over gaps in emergency allergy care. ALK Canada said an estimated up to 2. 5 million people in Canada are affected by severe allergies, and research shows that half of those living with a life-threatening allergy do not consistently carry their prescribed epinephrine auto-injector. The company also said approximately half do not administer an auto-injector when needed in an emergency.
neffy is designed to fit into a pocket for portability, with a 30-month shelf life from the time of manufacture and the ability to withstand temperature excursions up to 50°C. the spray delivers a full single dose of epinephrine in a user-friendly format without priming, and that freezing does not affect shelf life, although a frozen spray must thaw for at least one hour before use because it will not activate if frozen.
What experts and company leaders said
Dr. Anne Ellis, allergist and chair of the division of allergy and immunology at Queen’s University, said the gap between people at risk for anaphylaxis and people who actually carry self-administered epinephrine is a serious issue. She said anaphylaxis can occur within minutes of exposure and rapid treatment with epinephrine is critical to treatment success. Ellis added that many patients and caregivers do not carry their epinephrine autoinjector or hesitate to use it, often because of needle fear and uncertainty about correct administration. She said a needle-free nasal spray that people can use confidently and easily may help improve how quickly and effectively people respond.
Andrew Desbarats, General Manager of ALK Canada, said the approval of neffy marks a significant step forward in the treatment of anaphylaxis in more than 35 years. He said the company is providing a needle-free, portable epinephrine spray to help Canadians living with life-threatening allergies carry treatment wherever life takes them.
Clinical data and next steps for neffy
neffy 2 mg was approved in Canada after clinical studies involving more than 700 participants. No serious side effects were reported. The most frequently occurring adverse reactions were reported only after a second 2 mg dose, and included throat irritation, headache, nasal discomfort and feeling jittery.
Beyond Canada, the product is also approved in the United States and Japan, as well as the European Union and United Kingdom, where it is known as EURneffy. For now, Canadians can register for notifications while waiting for the pharmacy rollout. With the approval now in place, neffy moves from regulatory milestone to the next test: whether patients and caregivers adopt a needle-free option when anaphylaxis strikes.
