Epinephrine Nasal Spray Gets FDA Approval

The Food and Drug Administration (FDA) has approved an epinephrine nasal spray for severe allergic reactions, the first treatment for those reactions and anaphylaxis that is not administered by injection.

Anaphylaxis is a severe, life-threatening allergic reaction that can be brought on by insect bites, foods, medications or latex. Symptoms vary but can include a swollen throat or swollen areas of the body, wheezing, chest tightness, trouble breathing, trouble swallowing, unconsciousness and more. Epinephrine is the only lifesaving treatment for anaphylaxis.

The FDA approval for neffy, developed by California-based ARS Pharmaceuticals, Inc. came Friday (Aug. 9). ARS says the approval represents the first significant innovation in the delivery of epinephrine in more than 35 years and is the first and only needle-free treatment option for patients and families living with severe allergic reactions.

Kelly Stone, MD, Associate Director of the Division of Pulmonology, Allergy and Critical Care in the FDA’s Center for Drug Evaluation and Research, said in a statement that some people, particularly children, may delay or avoid treatment because of 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. Stone says.

Robert Zemble, MD, Chief, Division of Allergy, Lehigh Valley Health Network, says neffy’s development has been on the radar for allergists and immunologists.

“Having another option for the delivery of epinephrine that can cause less anxiety among patients is helpful,” Dr. Zemble says. “Time is of the essence when you’re having a severe allergic reaction. It will put people’s minds at ease to have a needle-free option for their kids.”

ARS, on its website, estimates approximately 25 million to 40 million people in the U.S. have experienced severe type 1 allergic reactions that may lead to anaphylaxis, but only about 3.3 million of them filled a prescription in 2021 for an epinephrine intramuscular injectable device, including autoinjectors.

ARS says of those 3.3 million people, roughly half don't carry these devices because of many drawbacks that can result in patient and caregiver injury, hesitation and delays in administration principally because of apprehension and pain of needles.

In turn, ARS says the failure or delay of epinephrine delivery can allow the allergic reaction to progress in severity causing life-threatening symptoms or events that potentially require emergency services or hospitalization. A type 1 allergic reaction is defined as an immediate overreaction to an otherwise harmless substance.

The Journal of the American Medical Association (JAMA) noted in 2021 that tens of thousands of anaphylactic reactions occur each year. JAMA noted the risk of death among those who suffer a reaction has been estimated to be about 1 percent with as many as 500 to 1,000 deaths annually.

ARS says neffy is expected to be available in the U.S. within eight weeks of FDA approval for people who weigh 66 pounds or more. The company says it will apply to the FDA by the end of September for approval of neffy for children who weigh 33-66 pounds.