Health Canada approves 1st needle-free epinephrine treatment for severe allergic reactions

Health Canada has approved the first needle-free epinephrine treatment for severe allergic reactions: a nasal spray called Neffy.

ALK Canada, which purchased the rights to distribute the drug, says the two-milligram treatment has been approved for adults and pediatric patients who weigh at least 30 kilograms — roughly 66 lbs.

It says the spray could be on the market as soon as this summer.

As it stands, epinephrine auto-injectors — known by the brand name EpiPen — are the only emergency treatment option available for allergic reactions.

EpiPens are single-use, pre-filled devices used to shoot a dose of epinephrine into the muscle.

Dr. Mariam Hanna, an adjunct clinical professor of pediatrics at Hamilton’s McMaster University, said Neffy’s non-needle delivery system is a plus for those who find it stressful or challenging to deploy auto-injectors.

“We are hoping that people are more ready to use it, and people will use it, in emergencies,” she said in an interview on Wednesday afternoon.

U.S. approved use in 2024

Neffy was approved for use in the United States in summer 2024, where it is also available in a one-milligram dose for kids who weigh 15 to 30 kilograms. That dose has not been approved in Canada.

A news release from ALK Canada says that the Neffy product is pocket-sized and has a shelf life of 30 months from its time of manufacture.

Hanna said Neffy’s emergence means that Canadians will now have more than one product they can choose from. That’s also useful in case supply is disrupted, as happened in 2018 with EpiPen auto-injectors.

“It’s great to have more than one option, and it’s fabulous that the other option doesn’t have a needle,” said Hanna.

Food Allergy Canada, a Toronto-based non-profit organization, is applauding the approval of the two-milligram treatment as “an important step forward” that gives Canadians more choices.