The purpose of this research is to see if Neffy nasal spray works as well as injected epinephrine for treatment of serious allergic reaction known as anaphylaxis. 

neffy is a new epinephrine nasal spray that has been approved by the United States (US) Food and Drug Administration (FDA) and European Union (EU) and European Medicines Agency (EMA) for the emergency treatment of Type I allergic reactions, including anaphylaxis. A needle-free epinephrine delivery is expected to have clinical benefits by reducing treatment apprehension and delay, reducing accidental injections, and making it easier to carry the product. The use of the Neffy spray in this study is investigational.

Epinephrine is used to treat life-threatening, allergic emergencies (e.g., insect stings or bites, foods, drugs, and other allergens). The other formulation that will be used in this study is an FDA-approved intramuscular (IM) epinephrine injection with a needle and syringe called Adrenalin®.  This is the commonly used formula used for allergy challenges and is administered by injection deep within your muscle to the upper outer side of your thigh.

If participants have an allergic reaction during an oral food allergy challenge or a planned allergy injection, they will get either the Neffy nasal spray or epinephrine injection to treat the reaction. The study staff will administer either the neffy device or the Adrenalin® intramuscularepinephrine injection. 

Participation will also include close monitoring of participants' vital signs and clinical condition for at least 2 hours after treatment, completion of several Quality of Life questionnaires and surveys to see how well they tolerated the treatment, and feelings about allergy reactions and treatments.

Total study participation will last approximately 6 months.