FDA Approves First Needle-Free Epinephrine Nasal Spray

ARS Pharmaceuticals has received approval from the FDA for its epinephrine nasal spray (neffy) for the emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh at least 66 pounds.¹ The therapy had previously been granted Fast Track Designation.

With the approval, the epinephrine nasal spray has become the first and only needle-free epinephrine alternative and the first new delivery method for epinephrine in over 3 decades.² The breakthrough treatment offers a new solution for individuals living with severe allergic reactions who fear needles or struggle with injections. Further, by eliminating the risk of needle-related injuries and reducing the typical bulk of epinephrine products, the easy-to-carry product represents a safe and accessible therapeutic option.

“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, associate director of the division of pulmonology, allergy, and critical care in the FDA’s Center for Drug Evaluation and Research, in a news release.¹ “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.”

The FDA’s decision to approve ARS Pharmaceuticals’ epinephrine nasal spray is supported by 4 studies in 175 healthy adults, without anaphylaxis, that measured the epinephrine concentrations in the blood following administration of the epinephrine nasal spray or approved epinephrine injection products.¹

Results showed that epinephrine nasal spray delivered comparable levels of epinephrine into the bloodstream as traditional injectable epinephrine products. Additionally, epinephrine nasal spray effectively increased blood pressure and heart rate, 2 crucial effects of epinephrine in treating anaphylaxis.

Studies also showed that children weighing over 66 pounds experienced similar epinephrine levels when using the nasal spray compared to adults.

READ MORE: An Evolving Understanding of Local Allergic Rhinitis

“Until today, patients with severe allergic reactions, including anaphylaxis, only had 1 treatment option—an often painful and anxiety-inducing needle injection of epinephrine. In some cases, patients would delay or not administer the life-saving treatment at the onset of symptoms, increasing the risk for a severe reaction or negative outcomes requiring additional emergency medical treatment,” said Thomas B. Casale, MD, professor of medicine and pediatrics and chief of clinical and translational research in the USF Health Morsani College of Medicine’s division of allergy and immunology at the University of South Florida in Tampa, Florda, in a news release.²

“FDA approval of neffy means that patients with severe allergies finally gain a long-waited, needle-free, easy-to-carry epinephrine delivery method that has the potential to reduce time to administration, which can lead to better clinical outcomes and improvements in quality of life for patients and their caregivers,” he continued.

ARS Pharmaceuticals submitted the New Drug Application for its epinephrine nasal spray to the FDA in August 2022. However, in September 2023, the FDA issued a Complete Response Letter requesting additional information, including completion of a repeat dose pharmacokinetic/pharmacodynamic study of epinephrine nasal spray under nasal allergen challenge conditions as well as completion of updated nitrosamine testing based on FDA guidelines.³

In February 2024, the company successfully completed the required repeat dosing study and nitrosamine testing, with no detectable levels of impurities found.

The FDA approval comes 2 months earlier than the originally anticipated PDUFA date of October 2, 2024.³

ARS Pharmaceuticals plans to roll out robust savings programs to support widespread access alongside the launch of epinephrine nasal spray.² For commercially insured patients, most will pay only $25 per prescription through a co-pay savings program; for uninsured or underinsured patients, the company will offer a cash price of $199. For eligible US residents who are uninsured or underinsured, meet certain eligibility requirements, and have exhausted all other options, the ARS Pharma Patient Assistance Program will provide the medication at no cost.

The epinephrine nasal spray is a single-dose treatment administered into 1 nostril. If symptoms don’t improve or worsen, a second dose can be used in the same nostril, similarly to epinephrine injection administration.¹

READ MORE: Allergy Resource Center

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References

1. FDA approves first nasal spray for treatment of anaphylaxis. News release. FDA. August 9, 2024. Accessed August 9, 2024. https://www.fda.gov/news-eveARS%20Pharmaceuticals.nts/press-announcements/fda-approves-first-nasal-spray-treatment-anaphylaxis

2. ARS Pharmaceuticals receives FDA approval of neffy (epinephrine nasal spray), the first and only needle-free treatment for type I allergic reactions, including anaphylaxis. News release. ARS Pharmaceuticals. August 9, 2024. Accessed August 9, 2024. https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-receives-fda-approval-neffyr-epinephrine

3. ARS Pharmaceeuticals submits response to FDA Complete Response Letter for neffy (epinephrine nasal spray). News release. ARS Pharmaceuticals. April 3, 2024. Accessed August 9, 2024. https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-submits-response-fda-complete-response