Neffy is now licensed by the FDA and EMA.

The licencing, introduction to the UK/EU market, and inclusion in the NHS will take some months, but hopefully, they will be available in the UK in 2025. 

• The FDA approval is for individuals weighing at least 30kg (for the 2mg dose), typically achieved at approximately ten years of age.

• Unless the license is extended to younger age groups, many families managing allergies will continue to rely on current Adrenaline Auto Injecter (AAI) devices.

• A 1mg dose license, which will serve patients weighing 15kg or more, will also be applied for.

• Administering adrenaline through an AAI presents significant limitations, including the fear associated with intramuscular injection, the complexity of administration, and unwieldy AAI device designs. Neffy's nasal route of administration is, therefore, a significant advancement. Its user-friendly design offers a more portable option, making it easier to carry than the AAI devices available in the UK, a particular problem for older children.

• Neffy may also have a longer shelf life and be more stable after exposure to higher environmental temperatures. 

• Medicines administered through the nasal route have also demonstrated effective systemic absorption in other conditions e.g. seizures 

• If and when Neffy becomes accessible, it will mitigate numerous limitations of traditional AAIs; nonetheless, some individuals may still exhibit reservations concerning adrenaline's potency.

• Adrenaline is a natural bodily hormone and a medicine commonly employed by dentists and anaesthetists for distinct purposes. 

• It is crucial to note that adrenaline does not modify the fundamental immune processes during anaphylaxis and does not always work! It functions as a natural "fuel" for the body, increasing heart rate, enhancing the strength of heart contractions, and facilitating airway dilation. Additionally, it effectively alleviates itchy hives, a common symptom of anaphylaxis. 

• The rapid metabolization of adrenaline through nasal and intramuscular routes may necessitate repeat administration. 

• Neffy is administered into one nostril; it allows for a second dose if symptoms do not improve or worsen.

• The second dose should be administered in the SAME nostril, the OPPOSITE of what we recommend for repeat AAI administration. 

• The approval of Neffy is based on four studies, including data from 175 healthy adults without anaphylaxis. These studies compared epinephrine concentrations in the blood following Neffy administration to approved epinephrine injection products. This data demonstrated comparable blood concentrations and physiological effects between Neffy and approved AAI devices.

• Common side effects of Neffy include throat irritation, nasal paresthesia, headache, nasal discomfort, jitteriness, fatigue, tremors, runny nose, nasal itchiness, sneezing, abdominal pain, gum pain, oral numbness, nasal congestion, dizziness, nausea, and vomiting.

• Adrenaline is essential in a comprehensive management plan for those at risk of more severe reactions, but it is sadly not always effective. As a community, we must continue to prevent and adequately treat allergies that may give rise to anaphylaxis. 

• More info - https://www.neffy.com/

• Prof George du Toit will review the Neffy data for presentation at the BSACI Global Allergy Online Symposium on Friday 17th January 2025.