The nasal spray was approved in the US and has been recommended for approval by EU regulators.
ADVERTISEMENTA nasal spray to treat life-threatening allergic reactions has been given the green light by US regulators.
Anaphylaxis, a severe and potentially fatal allergic reaction, requires immediate treatment with epinephrine, which is traditionally administered with an injection such as EpiPen.
The newly approved product “neffy” offers a needle-free alternative by delivering epinephrine through a nasal spray.
The spray is “the first epinephrine product for the treatment of anaphylaxis that is not administered by injection. Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections,” Kelly Stone, an associate director of the division of pulmonology, allergy and critical care in the US Food and Drug Administration (FDA)’s Centre for Drug Evaluation and Research, said in a statement.
“The availability of epinephrine nasal spray may reduce barriers to rapid treatment of anaphylaxis. As a result, neffy provides an important treatment option and addresses an unmet need,” Stone added.
The FDA says the spray is as effective at stopping dangerous reactions as the injections.
An allergic reaction occurs when a person's immune system overreacts to a substance.
Common triggers of anaphylaxis include certain foods, medications, and insect stings. Symptoms can arise within minutes and may include hives, swelling, itching, vomiting, difficulty breathing, and even loss of consciousness.
“This new delivery system is the first needleless delivery system for epinephrine,” Kelly Cleary, a senior director of the education and support programmes at the organisation Food Allergy Research & Education.
“What that means for individuals with food allergies and families with food allergies is that in an already anxiety-provoking moment of having this unintended response to an allergen where emotions are rising and you're worried about the health of yourself or your child, you now don't have to worry about the actual injection causing pain,” Cleary added.
‘Second chance at life’
Natalie DeMore, a 21-year-old college student in South Carolina, got special permission from the FDA to try neffy and has used it 15 times to halt reactions.
“Because of this, it's given me a second chance at life. I can live, I can go out. I can feel like I'm not being constantly followed by that shadow of death, literally the shadow of death. You know, I feel like I have control over my life. I feel like I don't have to be a prisoner to my disease,” DeMore added.
She has severe allergies to coconut, pineapple and palm oil and suffers up to 50 reactions a year, often requiring two to three injections per episode.
Each time, the injections leave her with severe, cramping leg pain that lasts days and makes her dread the next reaction, DeMore said.
“Things I start feeling when I have anaphylaxis is usually, it goes straight to my stomach. If it’s ingested, it'll go straight to a weird gurgling and pain…It goes to my upper sternum area, and then that's when I start to feel the chest tightness,” said DeMore.
ADVERTISEMENTNeffy is expected to be available with a prescription by mid-November in the US.
It can treat adults and children weighing at least 30 kg, but a version for smaller children is still under review.
EU regulators recommended the nasal spray for approval in June. ARS Pharmaceuticals, the company behind the nasal spray, plans for a commercial launch in the last quarter of 2024.
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