Needle-free epinephrine is coming to Canadian pharmacies starting this summer.
ALK-Abello Pharmaceuticals Canada announced that the Health Canada agency approved the neffy 2 mg epinephrine nasal spray on April 15.
The compact device is for the treatment of allergic reactions and anaphylaxis in children and adults who weigh 30 kilograms (66 pounds) and over.
Allergic Living followers in Canada with severe allergies have expressed much interest in neffy, the popular, needle-free epinephrine alternative to an auto-injector. Produced by ARS Pharmaceuticals, it won FDA approval in the United States back in August 2024.
“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,” said Andrew Desbarats, ALK Canada’s general manager. (ALK-Abello is the distributor of neffy in Canada, the EU and the UK.)
Dr. Anne Ellis, an Ontario allergist, noted the well-known issue of patients having severe allergic reactions hesitating to use epinephrine auto-injectors when needed. “A needle-free nasal spray that people can use confidently and easily may help improve how quickly and effectively people respond to an anaphylactic reaction,” she said.
Neffy for Smaller Kids in Canada
Richard Lowenthal, ARS Pharma’s President and CEO, says his company plans to file for approval of the neffy 1 mg dose with Health Canada by the summer of 2026. That device is for kids who weigh less than 30 kg (but more than 15 kg).
He also noted the device’s 30-month shelf life and its resistance to higher and colder temperatures.
Neffy becomes the second epinephrine device available in Canada. In recent years, only the branded EpiPen auto-injector has been available. The nonprofit Food Allergy Canada welcomed the epinephrine spray’s arrival. It noted that the device’s approval once again gives Canadians a choice of devices.
Neffy has gained approval in many regions, including Europe, the UK, Japan, China and Australia.
Q&A with Andrew Desbarats, General Manager ALK Canada
In Canada, the EpiPen has been the sole epinephrine device available. How important is it to have neffy available to Canadians, too?
Right now, if you or your child has been prescribed epinephrine, the only option has been an auto-injector. And we know from research that about half of people prescribed these devices don’t carry them consistently, and roughly half don’t use them when needed in an emergency. That’s a real problem when we’re talking about potentially life-threatening situations.
neffy® gives people a needle-free option that has a longer shelf life and can withstand higher temperatures than auto-injectors. This means less worry about expiration dates or whether it’s been sitting in a hot car.
But there’s another critical piece here: supply security. Canada has experienced epinephrine shortages before, and having only one product on the market creates vulnerability. In fact, epinephrine is on Health Canada’s draft Critical and Vulnerable Drug List precisely because of these supply concerns. This makes having another treatment option for Canadians all the more important.
Tell Canadians about the launch. When will they be able to find neffy at the pharmacy?
Now that Health Canada has approved neffy®, we’re working to make neffy® available at pharmacies across Canada as quickly as possible and expect it to be available in summer 2026. The best way for people to stay informed of availability is by registering for updates at neffy.ca.
Of note, neffy® is the first major innovation in anaphylaxis treatment in over 35 years.
Will neffy come in a 2-sprayer package or as individual devices?
neffy® will be available in a 2-pack. This is in line with recommendations that people with life-threatening allergies have at least two epinephrine devices on hand, in case a second dose is needed during an anaphylactic reaction.
Canadians have heard about the issues in the U.S. with some insurers denying coverage of neffy. Should it be smoother sailing for Canadians with prescription drug coverage?
Each country has its own mechanism for drug reimbursement. In Canada, ALK has completed submissions for neffy® to Canada’s Drug Agency (CDA) and Institut national d’excellence en santé et services sociaux (INESSS), a key step to securing public drug coverage. ALK has also submitted neffy® to all insurance companies for reimbursement consideration.
Every province and insurer will make their own coverage decisions, so ALK cannot comment on what coverage decisions and timelines will look like. We are committed to working with public and private payers to ensure that neffy® is accessible as fast as possible.
Will Canadian consumers with severe allergies also be able to purchase neffy for a cash price with a pharmacist without a prescription, as they can with an EpiPen? Is there a retail price range yet?
Currently, epinephrine auto-injectors are classified as behind-the-counter medications and are available without a doctor’s prescription through a pharmacist. Until the National Association of Pharmacy Regulatory Authorities (NAPRA) assigns the same scheduling to neffy®, it will be available only through a doctor’s prescription.
People paying out of pocket can expect the annual cost of neffy® (two spray devices) to be similar to that of two epinephrine auto-injectors. [Editor’s note: the out-of-pocket price for two EpiPens in Canada ranges between $200 and $320, depending on the retailer.]
neffy® delivers a full, single dose of epinephrine in a user-friendly format, without the need for priming. It also has a longer shelf life and can withstand higher temperatures than auto-injectors.
Health Canada approved the neffy 2 mg for those over 30 kg. What is the status of the neffy 1 mg in Canada, for younger children?
We plan to file for approval of the neffy® 1 mg dose with Health Canada in the coming weeks. Health Canada’s target review times for new drug submissions are generally 300 calendar days for standard submissions.
It’s vital to use epinephrine promptly in a severe allergic reaction. Yet, hesitation to use epinephrine auto-injectors is well-known. How can neffy make a difference with epi hesitation?
Reactions can escalate within minutes of exposure to an allergen, so it’s important to recognize the signs early and act fast. neffy® is a needle-free, portable epinephrine nasal spray that delivers a single dose of epinephrine in a user-friendly format, with no priming required. That simplicity and ease of use may help people feel more confident using epinephrine when they need it most.
Lastly, people wonder about using neffy when congested during an allergic reaction. Can you explain why this has not proved to be a concern in clinical studies?
Research has been done on neffy® in real-world scenarios, including when people had congestion from colds or allergies. What researchers found was that neffy® delivered a similar response to epinephrine auto-injectors in both situations: with congestion and without it.
Canadians can learn more at the neffy.ca website.
Related Reading:
FDA Drops Age Limit on Kids’ Neffy Epi Spray, Widening Access
Neffy Epi Spray Works Even If You Sniff, Stands Up Well to Extreme Heat
