Allergy Blog
Neffy Frequently Asked Questions
Sep
Neffy Nasal Epinephrine Spray – Frequently Asked Questions
Big news in allergy treatment! In August 2024, Neffy® 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). 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 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). ARS Pharma plans to file another application with the FDA for neffy for children who weigh between 15 to 30 kilograms later in 2024.
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 who weigh about 66 pounds or more (30 kilograms). It is already available for pre-order through the neffyConnect service, which can be accessed via neffy.com. The product is expected to be available to patients by the end of September.
Europe and EURneffy® – The European Commission approved EURneffy for the emergency treatment of allergic reactions (anaphylaxis) on August 22, 2024. It also allows for it to be sold in Norway & Iceland. Germany is currently planned to be the first EU country where EURneffy could be available, around year-end, followed by other countries.
United Kingdom & neffy – In the U.K., ARS Pharmaceuticals anticipates filing for approval from MHRA by Q4 2024, under their Mutual Recognition Process A, where MHRA will review and approve EURneffy based on the EMA approval within 60 days of filing. Thus, ARS Pharmaceuticals anticipates approval by Q1 2025 in the U.K. and launch by Summer 2025.
Canada & neffy – In Canada ARS anticipates filing for approval from Health Canada by Q4 2024
Australia and New Zealand & neffy – Plans are in place to secure regulatory, pricing and reimbursement approvals through our regional partner, CSL, with the view that neffy will be available in Australia and New Zealand shortly thereafter. Filings are anticipated by Q4 2024 in Australia.
China and Japan & neffy– regulatory submissions for approval in both China and Japan are anticipated to be filed by partner companies of ARS Pharmaceuticals by end of 2024. For China the review process is six months based on the U.S. FDA approval. For Japan, the approval process is anticipated to take approximately one year. Our partners, Pediatrix in China and Alfresa in Japan should launch neffy shortly after approval.
What do you think? Are you excited to see an alternative to needle-based epinephrine auto-injectors? Let us know in the comment 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