ARS Pharmaceuticals and ALK announced that Canadian regulators have approved a 2 mg dose of neffy epinephrine nasal spray for the treatment of anaphylaxis in adults and children who weigh at least 30 kg. The companies said that they expect neffy to be launched in Canada within a few months and that ALK plans to submit an application for a 1 mg dose for children between 15 and 30 kg by the end of the year.
ALK-Abelló acquired Canadian rights to neffy in November 2024, along with the rights to EURneffy intranasal adrenaline in Europe and the UK. EURneffy 2 mg was approved by the EMA for people weighing at least 30 kg in August 2024, and earlier this year, ALK announced that the the EMA’s Committee for Medicinal Products for Human Use recommended approval of the 1 mg pediatric dose.
In the US, where ARS has a co-promotion agreement with ALK, a 2 mg dose of neffy was approved in August 2024 for the treatment of anaphylaxis in patients who weigh 66 lbs (30 kg) or more. The FDA approved a 1 mg dose for children aged 4 or over who weighed 33-66 lbs (15-30 kg) in March 2025, and the agency recently approved removal of the age restriction for that dose.
In Asia, the 2 mg dose of neffy was approved in China for patients who weigh 30 kg or more in December 2025. ARS says that it expects Chinese rights holder Pediatrix to submit an application to the NMPA for the 1 mg dose in the next few months. The Japanese PMDA approved both doses in September 2025.
ARS Pharmaceuticals President and CEO Richard Lowenthal commented, “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 anaphylaxis in Canada, delivering the first needle-free epinephrine for use at the first signs of an allergic reaction. . . . 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.”
ALK Executive VP, Commercial Operations North America, Edward Jordan said, “We welcome the approval which marks an important milestone for people in Canada living with the risk of severe allergic reactions. neffy2 mg brings a portable, needle-free treatment option designed to help patients and caregivers act quickly and confidently when every minute matters.”
Read the ARS Pharmaceuticals press release
Read the ALK press release
