Allergy sufferers in Canada may be able to swap their EpiPen injections for a nasal spray as early as next year.
Neffy, made by drugmaker ARS Pharmaceuticals Inc., is the first epinephrine nasal spray to be approved in the United States to treat life-threatening allergic reactions known as anaphylaxis.
The U.S. Food and Drug Administration (FDA) green-lit the device on Aug. 9 for the emergency treatment of severe allergic reactions, including those that are life-threatening, in adults and older children.
Health Canada told Global News on Monday that it has not yet received a submission for Neffy, but the company says is it planning to file later this year.
“ARS anticipates filing for approval from Heath Canada by Q4 2024,” Richard Lowenthal, CEO of ARS Pharmaceuticals, said in an emailed response to Global News.
“It may take Health Canada up to 10 months to approve but hopefully sooner, so likely availability in Canada is late 2025.”
Experts say having a needle-free alternative to the EpiPen injection is “a very significant step forward” as it gives people more options to treat their allergies and could also increase uptake of epinephrine, which is the first line of treatment for anaphylaxis.
Jennifer Lake, a pharmacist and assistant professor at the University of Toronto’s Leslie Dan Faculty of Pharmacy, said allergy sufferers who have anaphylaxis have only been able to inject epinephrine in the past.
“This really starts to broaden how people can treat their allergies,” she said.
“We’ll probably see not only people switching from injections to the nasal, but people who haven’t ever bought injections for their allergies getting the nasal for the first time, which is really what, as health-care professionals, we want to see is people being able to protect themselves.”
Anne Ellis, chair of the division of allergy and immunology at Queen’s University in Kingston, Ont., said the device can appeal to anyone “hesitant to inject themselves.”
Ellis, who was one of the consultants in Neffy’s development process, said there is often reluctance to use epinephrine when you are in the throes of an acute allergic reaction, especially among children.
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Delaying the administration of epinephrine increases the likelihood of late-phase reactions as well as mortality risks, which is why taking it early — as soon as the symptoms start — is encouraged.
“I think in particularly the pediatric population, this is going to be a huge step forward,” Ellis said.
How to use Neffy
Neffy is an intranasal epinephrine device to treat patients with Type I allergic reactions, including to food, medications and insect bites, that could lead to life-threatening anaphylaxis, according to ARS Pharmaceuticals.
Anaphylaxis occurs when the body’s immune system develops a sudden, unexpected reaction to a foreign substance, such as food, insect stings or medications.
Common symptoms which can occur within minutes of exposure, include hives, swelling, itching, vomiting and difficulty breathing.
Neffy is intended for people who weigh at least 30 kilograms (66 pounds).
It is given in a single dose sprayed into one nostril. A second dose can be given if the person’s symptoms don’t improve.
Ellis said the spray is inserted into the nostril, and pushing down on the plunger delivers two milligrams of epinephrine.
“That seems like a very high dose compared to what we give through an EpiPen, for example, which is only 0.3, but because it’s being delivered intranasally, so you do have to absorb it, and it’s just the way in which the medication works,” she said.
How does Neffy compare to the EpiPen?
Clinical trials of people experiencing potentially deadly reactions are difficult for ethical and pragmatic reasons.
Instead, ARS officials compared the effect of the nasal spray on biological markers with existing epinephrine treatments.
Results of four studies in 175 healthy adults, without anaphylaxis, showed Neffy worked about as well as injected epinephrine to boost heart rate and blood pressure, which counter severe reactions.
“This (nasal spray) has the same amount of drug getting to the blood as the injection, because it’s a bit of a bigger dose,” Lake said.
“It has an additive that helps increase the absorption in the nose, so it should work exactly the same.”
Ellis added that since Neffy is comparable to an EpiPen, “the idea is that you can use this instead of an injection.”
However, because the drug is administered in the nose and not injected, the side effects might be a little different, Lake said.
According to the FDA, some of the most common side effects of Neffy include throat irritation, tingling nose, headache, nasal discomfort, fatigue, runny nose, sneezing, abdominal pain, gum pain, numbness in the mouth, nasal congestion, dizziness, nausea and vomiting.
The FDA said Neffy’s absorption may be affected if people have certain conditions, such as nasal polyps, or have had nasal surgeries, so they should consult a health-care professional to consider the EpiPen injection.
More than three million Canadians suffer from at least one allergy and there is no cure, according to Food Allergy Canada.
Neffy is expected to be available in the U.S. by early October – which is within eight weeks of the FDA approval.
If this product does get submitted to and is approved by Health Canada, Canadians will have to wait till next year at least.
— with files from The Associated Press