The first needle-free epinephrine treatment for severe allergic reactions has received approval from Health Canada.
An epinephrine auto-injector, better known by the brand name EpiPen, is the only emergency treatment option currently on the market in Canada for allergic reactions. But that is expected to change within the next few months.
Neffy, a two-milligram nasal spray treatment, has been approved by the government agency for use by adults and children who weigh at least 30 kilograms (66 pounds), according to an April 15 press release from ALK Canada, which has acquired the distribution rights for the drug. It is expected to become available in Canadian pharmacies this summer.
“The approval of neffy marks a significant step forward in the treatment of anaphylaxis in more than 35 years,” ALK Canada general manager Andrew Desbarats said in the press release. “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 received approval in Canada on April 9 after ALK Canada hosted clinical trials that included more than 700 participants.
No serious side effects were reported during the course of the trials, the press release said. Adverse reactions were only reported following a second 2 milligram dose for a total of 4 milligrams. The most common side effects at that dosage were throat irritation at 18.8 percent, headache at 17.6 percent, nasal discomfort at 12.9 percent, and feelings of jitteriness at 10.6 percent.
Health Canada lists neffy as approved in its database, but does not offer any comment or information beyond the specifications of the product.
Neffy is designed to provide fast absorption of epinephrine in a single dose and can act as a replacement for EpiPens, which are single-use, pre-filled syringe-like devices that shoot a dose of epinephrine directly into the muscle, the company said. It is small enough to fit in a pocket and can withstand temperature excursions up to 50°C. The drug also comes with a 30-month shelf life from time of manufacture.
Food Allergy Canada applauded Health Canada’s approval of the two-milligram treatment and said in an April 15 press release that it actively advocated for the drug’s approval.
“Our advocacy has focused on ensuring there are a minimum of two affordable epinephrine device options available in Canada, helping to reduce the risks associated with a single-source market, including supply shortages and limited flexibility,” the organization said. “As new epinephrine device options continue to emerge, we remain committed to advocating strongly and consistently to ensure Canadians can access the full range of options.”
The drug was approved for use in the United States in the summer of 2024, where it is also available in a one-milligram dose for kids who weigh 15 to 30 kilograms. That dosage has yet to be approved in Canada.
It has also been approved in Japan, as well as in the European Union and United Kingdom, where it is known as EURneffy.
