The Food and Drug Administration (FDA) has declined approval for an alternative to epinephrine autoinjectors, requesting additional study for a nasal spray named "neffy," despite a prior FDA Advisory Committee recommendation
ARS Pharma, the maker of neffy, expressed surprise at the FDA's decision and intends to appeal while also completing the required study promptly
Approximately 32 million people in the United States have food allergies, with research indicating that anaphylaxis may result in up to 200 deaths annually
Neffy is a needle-free epinephrine treatment that can be easily administered without preparation or activation, similar to the nasal spray Narcan used for opioid overdoses
Neffy's unique solvent allows epinephrine to be absorbed by the nasal mucosa, offering a distinct advantage over traditional epinephrine administration from a vial
Data submitted to the FDA suggests that neffy performs similarly to injected epinephrine, which can yield variable results based on factors like age, weight, and body mass
Reported side effects of neffy include mild nasal discomfort, headache, runny nose, nausea, moderate dizziness, moderate vomiting, and mild throat irritation
Unlike traditional epinephrine autoinjectors, neffy nasal spray doesn't necessitate training, potentially making it more accessible in settings like schools, airplanes, and first-aid kits
A 2021 survey revealed that epinephrine autoinjectors were underused in severe allergic reactions among young patients due to various reasons, including fear and perception of reaction severity
A mother of a child with multiple food allergies expressed disappointment in the delay for an alternative to injectable epinephrine and the potential benefits of a nasal spray version