ARS Pharma Expands Global Reach Of Neffy With Canada Approval For Allergy Emergencies

ARS Pharmaceuticals has announced that Health Canada has approved neffy 2 mg, an epinephrine nasal spray, for the emergency treatment of severe allergic reactions, including anaphylaxis, in adults and children weighing 30 kg or more. The approval expands access to a needle-free treatment option for life-threatening allergic events, with availability in Canada expected by summer 2026.

The product will be commercialized in Canada by ALK-Abelló under an exclusive licensing agreement signed in 2024. Under this partnership, ARS Pharmaceuticals is responsible for manufacturing and supply, while ALK handles commercialization across Canada and other regions outside the U.S. The agreement includes significant milestone payments and potential royalties tied to sales performance.

“The approval of neffy by Health Canada marks a meaningful advancement for the more than 2.5 million people living with allergic reactions that could lead to anaphylaxis¹ in Canada, delivering the first needle-free epinephrine for use at the first signs of an allergic reaction,” said Richard Lowenthal, Co-founder, President and CEO of ARS Pharma. “neffy’s needle-free design reduces barriers to timely treatment while fitting more naturally into everyday life. It is easy to carry, simple to use, has a 30-month shelf life, temperature excursions up to 122oF (50oC), and, if accidentally frozen, can be used once thawed. In partnership with ALK Canada, we are focused on moving quickly to make neffy accessible across the country and helping people feel prepared in an allergic emergency.”

This approval follows a similar authorization in China by the National Medical Products Administration, where neffy was approved in December 2025 through a partnership with Pediatrix Therapeutics. Both companies are planning to pursue approval for a lower 1 mg dose for younger pediatric patients in their respective markets.

Neffy is already available in the United States for patients weighing at least 15 kg, offering a non-invasive alternative to traditional injectable epinephrine. Its expansion into international markets highlights growing demand for user-friendly emergency treatments for anaphylaxis, particularly for pediatric and at-risk populations.