The U.S. Food and Drug Administration (FDA) approved the first-ever epinephrine nasal spray, Neffy, for the emergency treatment of allergic reactions, including life-threatening anaphylaxis.
The new treatment, a needle-free alternative, could be used for managing severe allergic responses in children and adults, weighing at least 66 pounds, the FDA said in a news release.
Allergic reactions occur from an overreactive immune response to a substance that typically does not cause any harm. While most reactions are mild, sometimes the immune response escalates within seconds or minutes, leading to a life-threatening emergency known as anaphylaxis. Common signs include a drop in blood pressure, rapid or weak pulse, skin rash, hives, itching, difficulty breathing, nausea, and vomiting.
Anaphylaxis requires immediate medical attention, typically with an injection of epinephrine. Neffy offers a simpler alternative: a single dose of nasal spray administered into one nostril. If symptoms don’t improve or worsen, a second dose can be given in the same nostril, similar to situations where a second epinephrine injection would be considered.
“Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections. The availability of epinephrine nasal spray may reduce barriers to rapid treatment of anaphylaxis. As a result, Neffy provides an important treatment option and addresses an unmet need,” Dr. Kelly Stone from the FDA’s Center for Drug Evaluation and Research said in a news release.
The FDA granted approval based on four studies involving 175 healthy adults without anaphylaxis. These studies measured the blood concentrations of epinephrine after Neffy was administered and compared them with those from traditional epinephrine injection products.
“Results from these studies showed comparable epinephrine blood concentrations between Neffy and approved epinephrine injection products. Neffy also demonstrated…
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