Allergy Blog
Neffy Frequently Asked Questions
Sep
Neffy Nasal Epinephrine Spray – Frequently Asked Questions
Big news in allergy treatment! In August 2024, Neffy® 2mg the first-ever epinephrine nasal spray, for the emergency treatment of allergic reactions (anaphylaxis) in adults and children over 66 pounds (30 kilograms) was approved by the FDA (neffy) and by The European Commission (EURneffy). In the U.S. the FDA has approved neffy® 1mg for children age four and older who weigh 15 – 30 kilograms.
This needle-free option is a game-changer, making it easier and less intimidating for those managing severe allergies to access life-saving treatment. As an allergy parent and previous health care professional, I was pretty excited to read up on this new innovative product and did some research to answer frequently asked questions that you may have as an allergy parent or individual managing serious allergies.
What is neffy? – neffy is a nasal epinephrine spray used to treat life-threatening, allergic emergencies, including anaphylaxis in adults and children who weigh 66 lbs or more (30 kg or more).
How big is Neffy – Neffy is similar in size to an earbud case, it fits in the palm of your hand making it easier to carry in a pocket
How many doses does 1 neffy device have? – Each neffy device contains a single dose. It will be dispensed as a twin pack.
Is neffy as effective as an epinephrine auto-injector? – It is a higher dose than that delivered by needle-based auto-injectors, 2mg of epinephrine per nasal spray to allow for nasal absorption. Clinical trials have shown that neffy is as effective as approved needle-based epinephrine auto-injectors in delivering the necessary dose of epinephrine to treat severe allergic reactions.
Does neffy still work if my nose is congested or if I have a cold? – Clinical tests suggest that upper respiratory tract infections, allergic rhinitis or nasal congestion do not negatively impact the absorption of or system levels of epinephrine from neffy nasal spray
If a patient is unconscious, can someone else administer the nasal spray on their behalf? – neffy can be administered in patients who are unconscious or cannot breathe, as neffy does not require inhalation since the medication is absorbed through the nasal mucosa. neffy can be administered while the patient is in any position (i.e., supine, semi-supine, standing, or sitting). The device is designed to function the same regardless of dosing position and delivers an accurate dose at any angle of use.
Who can use neffy? – neffy 2mg will be for use in adults and children over 66 pounds (30 kilograms). In the U.S. the FDA has approved neffy® 1mg for children age four and older who weigh 15 – 30 kilograms
How much will neffy cost? It is expected to cost roughly the same as needle-based auto-injectors, but it will have a much longer expiry date
neffy storage temperature – It is recommended to store neffy at 20°C to 25°C (at 68°F to 77°F). Temporary excursions are permitted up to 50°C (122°F).
neffy states, “Do not Freeze,” and if frozen, neffy will not deliver epinephrine while frozen and may take up to 20 minutes to thaw. However, if accidentally frozen (below -15°C or 5°F (5°F)) studies showed it is still effective after thawing.
What expiry dates will neffy have? – neffy will have a 24-month shelf life from the date of manufacture.
Neffy does have some risks associated with certain coexisting conditions so please consult your health care provider for any medical advice concerns or contraindications.
Where will neffy be available?
USA & neffy – In the U.S. the FDA has approved neffy® for adults and children age four and older who weigh at least 15 kilograms. It is commercially available through the neffyConnect service, which can be accessed via neffy.com
Europe and EURneffy® – The European Commission approved EURneffy for the emergency treatment of allergic reactions (anaphylaxis) in adults and children who weigh greater than 30 kg on August 22, 2024. It also allows for it to be sold in Norway & Iceland. It may be launched in Ireland in 2026. Germany is the first EU country where EURneffy has been launched and is now available to be prescribed by physicians.
United Kingdom & EURneffy® – The United Kingdom (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for EURneffy (adrenaline nasal spray) for the emergency treatment of allergic reactions (anaphylaxis) in adults and children who weigh greater than 30 kg. It is expected to be available by Q4 2025 in the U.K.
Canada & neffy – Regulatory approvals for neffy in Canada (with ALK) is expected by the end of 2025, with commercial rollouts planned for early 2026
Australia and New Zealand & neffy – Plans are in place to secure regulatory, pricing and reimbursement approvals through a regional partner by the end of 2025 with the view that neffy will be available in Australia and New Zealand shortly thereafter.
China and Japan & neffy – For Japan, regulatory approvals for neffy is expected by the end of 2025 and in China during 2026
What do you think? Are you excited to see an alternative to needle-based epinephrine auto-injectors? Let us know in the comments section
Blog Author: Anne Walsh, Msc Biomedical Science
Sources:
https://community.kidswithfoodallergies.org/blog/fda-approves-neffy-epinephrine-nasal-spray-for-treating-severe-allergic-reactions
www.allergicliving.com/2024/07/06/eu-poised-to-approve-neffy-epi-spray-will-u-s-soon-follow/
Disclaimer: The information provided is for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis or treatment. Allergy Lifestyle Limited (t/a) Allergy Lifestyle) uses reasonable endeavours to check the accuracy of information provided however no warranty is given that they are error-free. Always seek the advice of an allergy specialist and follow your anaphylaxis emergency care
I am delighted to hear of this new product as it is my adult son who has the nut allergy as he is working now for many years how would he carry this product to work each day and when he gets there what way has it go be stored if they have not got a fridge thank you Ann o Donovan
Sounds perfect easier to carry as teenagers don’t like to carry bulky epi pen