FDA approves first-ever nasal spray for life-threatening allergies

If you, your child or a loved one are managing a life-threatening allergy, then you know what it’s like to have an EpiPen or Auvi-Q stashed in every bag to ward off anaphylaxis. The injectable epinephrine products can help save a life during an allergic reaction, but it can be daunting to use them. There’s never been a needle-free option, until now.

For the first time, a non-injection form of epinephrine has been approved by the FDA. Known as neffy,  the single-dose nasal spray is designed to be administered into one nostril, and was approved for use in adults and kids who weigh at least 66 pounds with severe allergies.

“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 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.”

Epinephrine has been used in the treatment of anaphylactic allergies since the early 1900s, and the injectable form of the drug has been the standard for the past 35 years, reports ARS Pharmaceuticals, the manufacturer of neffy. For those who may have a needle phobia, neffy is a game-changer.

“This approval marks a watershed moment in addressing an unmet medical need for people with Type I allergies – a treatment alternative that avoids the need to inject epinephrine with a needle, which can be fraught with anxiety and fear for many,” said Richard Lowenthal, Co-Founder, President and Chief Executive Officer, ARS Pharmaceuticals. “Epinephrine treatment is only effective if available, readily usable, and administered appropriately.”

The approval of neffy is based on four studies involving 175 healthy adults without anaphylaxis. These studies compared the blood concentrations of epinephrine after using neffy to those after using approved epinephrine injection products. The results showed comparable epinephrine levels in the blood, as well as similar increases in blood pressure and heart rate—critical effects in treating anaphylaxis.

For children weighing more than 66 pounds, a separate study demonstrated that epinephrine concentrations were similar to those in adults who received neffy.

As with injectable epinephrine products, a second dose of neffy may be administered if symptoms don’t improve or worsen. However, patients should still seek emergency medical assistance for close monitoring and potential further treatment—the same as with injectable epinephrine.

It’s important to note that neffy comes with certain warnings. People with nasal conditions like polyps or a history of nasal surgery should consult a healthcare professional, as these conditions may affect the absorption of the medication. Additionally, the product includes warnings about use in people with certain coexisting conditions and potential allergic reactions to sulfites.

Common side effects of neffy include throat irritation, nasal discomfort, headache and feeling jittery, among others. 

Neffy is expected to be available within eight weeks of FDA approval, the manufacturer said, and is expected to cost around $25 for those with insurance for two single-use neffy devices via a co-pay savings program.

Experts believe neffy will expand access to epinephrine, making it more available for use in areas where accidental exposures happen, like at restaurants, on airplanes and at hotels. “This is a win for the food allergy community,” said Sung Poblete, Ph.D., RN, CEO of FARE, a nonprofit organization dedicated to supporting those with food allergies. 

The FDA’s approval of neffy marks a significant step forward in allergy treatment, especially for those with a fear of injections.

“Anyone who has experienced or witnessed an anaphylaxis reaction knows it can be very stressful deciding when to inject epinephrine to themselves or a child and often delay,” said Dr. Jonathan Spergel, Chief of the Allergy Program at Children’s Hospital of Philadelphia, in a statement. “We know that earlier administration is better, and for many, the needle is a barrier that causes dangerous hesitation. That is why the field has long pursued an effective treatment approach that does not require an injection.”