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What is Neffy (nasal epinephrine)?

Medically reviewed by Carmen Pope, BPharm. Last updated on Aug 12, 2024.

Official answer

by Drugs.com

Neffy (epinephrine 2 mg/dose) is a nasal spray which may be given to treat a severe allergic reaction, including anaphylaxis, in adults and children who weigh 66 pounds (30kg) or more. It is needle-free and simple to administer. It is the first non-injectable treatment available for people with life-threatening allergic reactions and gained FDA approval on August 9, 2024.

How does Neffy work?

Neffy works in the same way as epinephrine injections, activating both alpha and beta receptors to constrict blood vessels to maintain blood pressure and heart function, and relax smooth muscles in the airways of the lungs to help relieve shortness of breath and wheezing. Epinephrine may also relax smooth muscles of the stomach and intestine to relieve digestive symptoms.

In a severe allergy, Neffy:

  • relaxes the airway muscles to help with breathing
  • constricts blood vessels to maintain blood pressure
  • reduces swelling, hives or itching that may occur around the face, eyes, or lips
  • stimulates the heart (increases heart rate)
  • prevents the release of histamine, which can further worsen allergies.

Who makes Neffy?

Neffy is made by ARS Pharmaceuticals. Other pharmaceutical companies are also investigating nasal epinephrine.

Is Neffy FDA-approved?

Neffy finally gained FDA approval on August 9, 2024 after the FDA held back approval in September, 2023, asking for further study.

In total, four studies in 175 healthy adults without anaphylaxis have shown comparable epinephrine blood concentrations between Neffy and approved epinephrine injection products. Neffy was also effective at triggering increases in blood pressure and heart rate that underpin the body's way of treating anaphylaxis.

How does Neffy compare to an Epipen?

Neffy is a needle-free nasal spray that is sprayed into the nose whereas Epipen is an injection that is given into a big muscle, such as the thigh.

Neffy contains 2mg of epinephrine per dose whereas an Epipen autoinjector contains 0.3mg per dose and an Epipen Junior auto-Injector, delivers 0.15 mg per dose. Neffy delivers a higher dose than Epipen because it is being given via the nose rather than by injection, so a higher dose is needed for the same effectiveness because an injection delivers medicine to the bloodstream more effectively.

Epipen is available in two autoinjectors:

  • Epipen for those who weigh at least 30 kg (approximately 66 pounds or more)
  • Epipen Junior for children who weigh 15 kg to 30 kg (33 pounds to 66 pounds)


Each Neffy nasal spray contains 2mg of epinephrine (one dose) and may be used in adults and children who weigh 66 pounds or more. One dose is sprayed into one nostril during an anaphylactic attack. If the first dose doesn't ease symptoms, the agency urges giving a second dose (from a new dispenser) into the same nostril. People receiving Neffy should be monitored closely after a dose, in case further treatment, including emergency medical help, is needed.

Research has also showed that people are more likely to use a nasal spray 18 minutes earlier than injectable epinephrine, and as many as 35 percent more people would carry one with them.

Related questions

What are the side effects of Neffy?

Neffy was mostly well tolerated in clinical trials and side effects were generally mild and included:

  • Throat irritation
  • Tingling nose
  • Headache
  • Nasal discomfort
  • Feeling jittery
  • Tingling sensation
  • Fatigue
  • Tremor
  • Runny nose
  • Itchiness inside the nose (nasal pruritus)
  • Sneezing
  • Abdominal pain
  • Gum pain
  • Numbness in the mouth
  • Nasal congestion
  • Dizziness
  • Nausea and vomiting.

Neffy carries the following warnings:

  • People with certain nasal conditions, such as nasal polyps or a history of nasal surgery, should consult with their healthcare provider to consider use of an injectable epinephrine product because these conditions may affect the absorption of Neffy
  • Neffy must be used cautiously by people with certain coexisting conditions, such as heart disease because it may aggravate angina or affect the heart beat
  • Neffy contains a sulfite but the presence of this in the product should not stop people allergic to sulfites from using it.
References
  • Neffy Package Insert. https://www.ars-pharma.com/wp-content/uploads/pdf/Prescribing_Information.pdf
  • FDA Approves First Nasal Spray to Curb Anaphylaxis, An Alternative to Injections. August 11, 2024. https://www.drugs.com/news/fda-approves-first-nasal-curb-anaphylaxis-alternative-injections-120725.html
  • Abbas M, Moussa M, Akel H. Type I Hypersensitivity Reaction. [Updated 2022 Jul 18]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK560561/
  • FDA Panel Recommends Approval of First Nasal Spray to Combat Severe Allergic Reactions. May 12, 2023. https://www.drugs.com/news/fda-panel-recommends-approval-first-nasal-combat-severe-allergic-reactions-112553.html
  • ARS Pharmaceuticals Announces FDA Acceptance of NDA for neffy® (epinephrine nasal spray) for the Treatment of Allergic Reactions (type I) Including Anaphylaxis. Oct 21, 2022. https://www.biospace.com/article/releases/ars-pharmaceuticals-announces-fda-acceptance-of-nda-for-neffy-epinephrine-nasal-spray-for-the-treatment-of-allergic-reactions-type-i-including-anaphylaxis/
  • FDA Wants More Data on Neffy, First Needle-Free Antidote for Severe Allergic Reactions. Sept 20, 2023. https://www.drugs.com/news/fda-wants-more-data-neffy-first-needle-free-antidote-severe-allergic-reactions-115090.html

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