FDA Approves First Emergency Allergy Nasal Spray

The first non-injectable emergency treatment for allergies is anticipated to hit shelves following FDA approval of the neffy epinephrine nasal spray.

The product from ARS Pharmaceuticals, previously called ARS-1, has been granted an indication for the emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh at least 66 pounds, the FDA said in a press release Friday.

The epinephrine product comes in a single-dose nasal spray administering a 2-mg dose into one nostril; a second dose may be delivered to the same nostril if there is no improvement in symptoms. With FDA’s blessing, the nasal spray is now positioned as an alternative to mainstream injectable epinephrine products that may provoke user fear due to their reliance on needles.

“Today’s 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,” said Kelly Stone, MD, PhD, of the FDA’s Center for Drug Evaluation and Research, in a statement. “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.”

ARS Pharmaceuticals said the spray is expected to be available in the U.S. within 8 weeks. People with commercial insurance can expect to pay $25 for each prescription of two single-use nasal sprays. People paying cash are offered a price of $199 for the two doses, and people meeting certain financial assistance criteria can get the medication at no cost under the ARS Pharma Patient Assistance Program.

Type I allergic reactions are the most widely known allergic reactions, with examples including food allergies, bee sting reactions, and penicillin allergies. Symptoms range from hives to swelling of the face to anaphylaxis.

FDA said it approved the epinephrine nasal spray based on four studies on 175 healthy adults without anaphylaxis. Results “showed comparable epinephrine blood concentrations between neffy and approved epinephrine injection products.”

The nasal spray comes with a warning that certain nasal conditions, such as nasal polyps or a history of nasal surgery, may affect absorption. Additionally, people with certain co-existing conditions and allergic reactions associated with sulfite are advised to use the epinephrine spray with caution.

Reported side effects of the spray include throat irritation, headache, nasal discomfort, feeling jittery, fatigue, tremor, runny nose, sneezing, abdominal pain, gum pain, nasal congestion, dizziness, nausea, and vomiting.

Nearly a year ago, FDA had declined to approve the spray on the basis of the need for additional pharmacokinetic (PK)/pharmacodynamic (PD) data. The surprising decision occurred a few months after FDA advisory committee members had voted in favor of the nasal spray.

By May, ARS Pharmaceuticals said it had already submitted its response to the FDA’s Complete Response Letter and addressed the additional request for positive data from a repeat dose PK/PD study of the product under nasal allergen challenge conditions, among other requests from the agency.

The company said that later this calendar year it will be filing a supplemental application for the epinephrine nasal spray to be used for smaller children.

The company is also testing the epinephrine nasal spray for patients with urticaria in a phase IIb trial, with a pivotal efficacy study in that setting scheduled to begin in 2025.

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