The US Food and Drug Administration (FDA) has approved ARS Pharmaceuticals' neffy (epinephrine nasal spray) 2mg for the emergency treatment of allergic reactions (type I).
The indications include life-threatening anaphylaxis in adults and children weighing a minimum of 30kg.
Previously, only injectable epinephrine was available for such patients.
Anaphylaxis is a severe allergic reaction that can quickly become fatal, necessitating immediate medical intervention.
Common triggers include certain foods, medications and insect stings, with symptoms such as hives, swelling, and difficulty breathing typically manifesting within minutes of exposure.
The approval of neffy is supported by data from four clinical studies involving 175 healthy adults.
These studies compared the blood concentration levels of epinephrine after administering neffy or traditional epinephrine injections.
The findings indicated that neffy delivers comparable epinephrine levels to those of injectable products.
In addition to matching the epinephrine blood concentrations, neffy demonstrated similar increases in blood pressure and heart rate, essential in managing anaphylaxis.
Further research in children weighing more than 30kg confirmed that the epinephrine concentrations were consistent with those observed in adults treated with neffy.
Neffy is administered as a single dose in one nostril and can be repeated with a new spray if symptoms persist or worsen.
Despite its ease of use, neffy comes with a warning regarding its absorption in patients with certain nasal conditions such as nasal polyps, or with a history of nasal surgery.
These individuals are advised to consult healthcare professionals regarding the use of injectable epinephrine.
The FDA has also highlighted that neffy should be used with caution by individuals with certain medical conditions and allergies to sulfite.
Common side effects reported include throat irritation, headache and nasal discomfort, among others.
Associate director of the FDA Center for Drug Evaluation and Research Division of Pulmonology, Allergy and Critical Care Kelly Stone said: “The approval provides the first epinephrine product for the treatment of anaphylaxis that is not administered by injection. 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.”
