first-ever nasal spray for severe allergic reactions gets approval in u.s.

a new method of treating anaphylaxis has been recently approved by the u.s. food and drug administration (fda) that can take the place of needles.

by angelica bottaro

aug 13 2024

4 minute read

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needle-free treatment for severe allergic reactions is on the horizon, as the fda has approved a new nasal spray in the u.s. getty images

for as long as people can remember, the only at-home way to curb a severe allergic reaction, also known as anaphylaxis, has been a needle to the thigh with an epipen or similar auto-injectors.

these needle devices give a shot of epinephrine, a form of adrenaline that acts as both a neurotransmitter and a hormone, to curb the symptoms of anaphylaxis so that a person experiencing a severe allergic reaction can seek emergency medical care.

when a severe allergic reaction hits, a person can experience life-threatening symptoms caused by the immune system’s release of chemicals that cause the body to go into a state of shock. these chemicals drive swelling in the throat or tongue, difficulty breathing, severe skin reactions, and, in the worst cases, death.

a new method of treating anaphylaxis has been recently approved by the u.s. food and drug administration (fda) that can take the place of needles. it’s a form of nasal spray that introduces the vital epinephrine into the system to help remedy anaphylaxis.

taking a page from the narcan book

nasal spray drugs are not new. one of the most notable, narcan, is used to reverse the effects of a potentially deadly opioid overdose. the drug in this nasal spray treatment is naloxone, and it has been highly effective in reducing the number of opioid overdoses in those who are at a higher risk.

the new drug used for allergic reactions, neffy, uses the same spray device as narcan, but instead of using naloxone, the spray administers epinephrine to help reverse the life-threatening effects of an allergic reaction.

approving the spray to address treatment avoidance

the spray has been approved for use in adults and children as long as they weigh over 66 pounds. it’s single-use and is designed to reduce the need for needles while allowing people to feel safe to be out in the world when they have severe allergies.

dr. kelly stone, associate director of the division of pulmonology, allergy, and critical care in the fda’s centre for drug evaluation and research, noted in a news release that “some people, particularly children, may delay or avoid treatment due to fear of injections.”

because of this avoidance, many people are put at a heightened risk of worsened outcomes because delaying treatment while in anaphylaxis can mean the difference between life and death.

the data that led to the approval

to ensure the new nasal spray method would work as well for allergic reactions as it does for those with opioid overdoses, the drug was tested in both children and adults. when measured against injected epinephrine, the results showed that the nasal spray was as viable as the injection, giving researchers the data they needed to bring it to the fda for approval.

the data also showed that nasal spray offers the same results regarding seeking care following an anaphylaxis attack. both the epi-pen and other auto injectables, as well as the nasal spray, require a person to seek emergency care after an allergic reaction. because the spray is on an even keel with the injectable epinephrine, it is considered a secondary option for people who cannot handle needles.

contraindications and side effects

the only difference between the two appears to be the administration, which could cause issues for some people with nasal conditions. for example, someone living with nasal polyps or those who have had nasal surgery may not benefit from neffy since the absorption of the drug may not be sufficient.

both methods of epinephrine administration have side effects as well. the epipen may induce paleness, dizziness, weakness, headaches, anxiety, fear, and restlessness. in contrast, the nasal spray can cause a person to develop side effects such as throat irritation, tingling in the nose, headache, nasal discomfort, and feeling jittery.

introducing a new treatment for a reason

the epipen and other auto injectables work well to help someone experiencing a severe allergic reaction. the reason for this new administration method doesn’t have much bearing on how it works but rather the stress that can come along with administering a needle to someone who’s experiencing anaphylaxis alongside a severe fear of needles.

dr. jonathan spergel, chief of the allergy program at children’s hospital in philadelphia, said in a news release that “anyone who has experienced or witnessed an anaphylaxis reaction knows it can be very stressful deciding when to inject epinephrine to themselves or a child.”

he also notes that because of that, treatment can be delayed. but with the new option, earlier administration is possible in these types of situations, improving outcomes for those who have these types of reactions to allergens.

others of its kind are also in development in the united states, making for more needle-free options for people living with severe allergies. while it’s not known when canadians will benefit from its use, the drug will be available in the united states in as little as eight weeks.

angelica bottaro

angelica bottaro is the lead editor at healthing.ca, and has been content writing for over a decade, specializing in all things health. her goal as a health journalist is to bring awareness and information to people that they can use as an additional tool toward their own optimal health.

first-ever nasal spray for severe allergic reactions gets approval in u.s.