Epinephrine nasal spray now available to treat type 1 allergic reactions, anaphylaxis

Epinephrine nasal spray now available to treat type I allergic reactions, anaphylaxis | Image Credit: © Saiful52 - © Saiful52 - stock.adobe.com.

Epinephrine nasal spray (neffy; ARS Pharmaceuticals) is available to patients and caregivers via prescription across the United States, according to an announcement from ARS Pharmaceuticals.¹

The nasal spray to treat type 1 allergic reactions, including anaphylaxis, in patients who weight at least 66 lbs (30 kg) was approved by the FDA on August 9, 2024.²

Approval was based on comparable epinephrine blood concentration data following administration of neffy or approved epinephrine injection products demonstrated in 4 studies comprising 175 healthy adults without anaphylaxis. Similar increases in blood pressure and heart rate were observed for neffy, compared to injection products, a pair of critical epinephrine effects when treating anaphylaxis.²

"The introduction of neffy is welcomed by the healthcare community,” said Carlos Camargo, MD DrPH, professor of Emergency Medicine at Massachusetts General Hospital and Harvard Medical School, in a press release. "Neffy changes the paradigm when it comes to treatment options for patients and families living with severe allergic reactions — and the way in which healthcare providers practice. Epinephrine auto-injectors have needles and this can be intimidating for patients. This can lead to hesitancy in carrying and in using the life-saving devices, and often results in patients failing to treat before seeking emergency medical assistance."¹

"We know that a lot of patients are reluctant to either inject themselves or inject their children with epinephrine because of needle phobia," said Thomas Casale, MD, professor of medicine, chief of Clinical and Translational Research, Allergy and Immunology, University of South Florida, in a previous interview with Contemporary Pediatrics. "Having alternatives is very important."²

ARS Pharmaceuticals is looking to further expand the pediatric indication for neffy, as the company has submitted a supplemental New Drug Application (sNDA) to the FDA for 1 mg use in pediatric patients who weigh 33 to 66 lbs (15 to 30 kg).¹

According to the availability announcement, "eligible commercially insured patients will pay $25 for two single-use neffy devices through a co-pay savings program," via neffyConnect, and in partnership with the online pharmacy BlinkRx.¹

"For patients without insurance coverage, or for those whose insurance plans do not yet cover neffy, ARS Pharmaceuticals is offering a cash price of $199 for two single-use neffy devices. neffy will be available free of charge for patients that qualify for the ARS Patient Assistance Program. Starting today, national retail pharmacies will also begin stocking neffy and a $25 co-pay savings card can be downloaded at neffy.com for use at pharmacies by eligible patients," ARS stated in the announcement.¹

Pre-ordering for neffy began on September 4, 2024.³

References:

1. ARS Pharmaceuticals Announces U.S. Availability of neffy (epinephrine nasal spray), the First and Only Needle-Free Treatment for Type I Allergic Reactions, Including Anaphylaxis. ARS Pharmaceuticals. Press release. September 23, 2024. Accessed September 2024. https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-announces-us-availability-neffyr-epinephrine
2. Fitch, J. FDA approves neffy as first nasal spray to treat anaphylaxis. Contemporary Pediatrics. August 9, 2024. Accessed September 2024. https://www.contemporarypediatrics.com/view/fda-approves-neffy-as-first-nasal-spray-to-treat-anaphylaxis
3. Fitch, J. ARS launches pre-ordering for neffy to treat type 1 allergic reactions. Contemporary Pediatrics. September 4, 2024. Accessed September 2024. https://www.contemporarypediatrics.com/view/ars-launches-pre-ordering-neffy-treat-type-1-allergic-reactions