Anaphylaxis: Does Neffy's arrival on the Canadian market threaten EpiPen?

Approved last April by Health Canada, the Neffy nasal spray, the first needle-free epinephrine treatment for severe allergic reactions, has been available in Canada since Aug. 5, 2026. This 2 mg treatment is approved for adults and children weighing at least 30 kg. The 1 mg Neffy was already approved in the United States for children weighing between 15 and 30 kg. Until now, epinephrine auto-injectors remained the only emergency treatment option available for severe allergic reactions in Canada.The arrival of the nasal spray represents a real clinical opportunity, according to Dr. François Graham, allergist and clinical immunologist in the Department of Medicine at Centre hospitalier de l'Université de Montréal (CHUM). According to him, the approval of Neffy is based on pharmacokinetic and pharmacodynamic studies in healthy subjects that Health Canada considers sufficiently similar to those of EpiPen to conclude that there are comparable benefits.Real-world data supports this finding, he adds. In an observational program of 545 patients treated with Neffy for anaphylaxis, approximately 89% responded to a single dose, a rate essentially identical to that historically reported with epinephrine injection. “Although this is not a large-scale, direct comparative trial in community-based anaphylaxis, these results support the idea of comparable clinical efficacy between the two devices,” he told Profession Santé.These results deserve to be validated, continues Jean-François Bussières, former head of the Pharmacy Department at CHU Ste-Justine and head of the Pharmaceutical Practice Research Unit (URPP) at the University of Montreal. “Before getting carried away, we’ll need to validate in the literature whether the efficacy and administration success are truly comparable,” he emphasizes. “But I must recognize that, from a therapeutic standpoint, this represents a definite interest for my hospital pharmacist colleagues.”“Neffy has the potential to capture a significant market share.”Despite this, could Neffy truly compete with EpiPen among the general public and healthcare professionals? It’s likely, says Philippe Bégin, director of the Oral Immunotherapy Clinic (CITO) at CHU Ste-Justine.“EpiPen has consistently resisted the arrival of competitors in the past, but this time, it’s a truly different product.”Different, and at first glance much more advantageous for the general public, says Dr. François Graham: “I think Neffy has the potential to capture a significant market share, because it’s a product that has a lot going for it for patients: longer lifespan, stability in extreme temperatures, and above all, intranasal administration rather than an injection, which often frightens patients or delays treatment.”Indeed, according to a recent online survey¹ conducted by OnePoll on behalf of ALK Canada (distributor of Neffy in Canada) among 2,000 nationally representative Canadians, nearly half (49%) say they would not feel comfortable using an epinephrine auto-injector in an emergency.Also, injector shortages and frequent product recalls are not working in EpiPen's favour, notes Jean-François Bussières. "This puts patients in precarious situations with expired devices. The arrival of an alternative is therefore good news for the market."But according to him, the market share Neffy could carve out is primarily in outpatient settings, "for a child or an allergic adult who is afraid of needles and would be more comfortable with the nasal route." Since hospital-based anaphylaxis treatment protocols are very strict, clinicians will continue to use the injectable route.Moreover, even in outpatient settings, EpiPen is already well established in the routines of patients with severe allergies, who know how to use it—either on themselves or with someone else's help—and it proves more practical in various situations, the pharmacist points out."It's a procedure that can be performed even if the patient is unconscious. Accessing the nostrils of someone who has fallen, is agitated, or is experiencing severe symptoms could be more complicated.""For a young patient who goes to day camp, for example, [Neffy] can reassure the monitors, but proper training remains essential: if the patient moves and the spray is administered outside, the dose is lost," he observes.A device that still needs to prove itselfInstead of hindering EpiPen sales, the arrival of Neffy, "which meets a clear need," could even have the opposite effect and boost them, says Bégin. According to him, the mere fact that an alternative option is coming onto the market will prompt doctors and pharmacists to discuss the issue with their patients, sparking "teaching opportunities, regardless of the final device chosen."“This can raise awareness about the importance of knowing how to use your device and always having a spare on hand,” says Bégin.“According to Canadian guidelines, which changed three years ago, it’s no longer necessary to go to the emergency room after using epinephrine, and that was a significant barrier to its use. However, this guideline is not widely known,” he says. Indeed, not everyone is affected by this new device. While EpiPen is available in 0.3 mg doses for adults and 0.15 mg doses for children via intramuscular injection, Neffy is only approved in Canada for patients weighing 30 kg or more with a 2 mg dose. “A large portion of the pediatric population therefore does not yet have access to it,” observes Dr. Graham.Finally, the economic argument will obviously be a major factor, the three experts agree. “Will the public system agree to cover this cost if the clinical benefit isn’t greater?” asks Bussières. “As a hospital pharmacist, I’m very aware of the importance of using resources wisely.”“We’ll therefore need to take a step back, monitor the evolution of clinical data, and, if the economic aspect allows, define a clear therapeutic niche for this product.”Dr. Graham is also waiting to see what happens. “We’ve learned in the past that several new devices have struggled to gain a lasting foothold, such as Emerade, which was withdrawn due to a risk of device failure, or Allerject, which experienced recurring recalls and supply disruptions over the years,” he recalls. “I think the price and the real-life experience will determine whether Neffy is a true success.”This article has been translated from its original French and first appeared on our sister site Profession Santé. Reference:OnePoll (2026). Consumer Survey. ALK-Abello Pharmaceuticals Inc. Canada

Anaphylaxis: Does Neffy's arrival on the Canadian market threaten EpiPen?

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