The First Needle-Free Alternative to the EpiPen Is a Potentially Lifesaving Nasal Spray

Key Takeaways

• The FDA just approved an epinephrine nasal spray option for serious allergic reactions triggered by problem foods, medicines, or insect stings.
• Previously, people who needed epinephrine needed to get injections from a healthcare professional or to self-administer the drug with an EpiPen.
• The new medication will expand options for adults and children who fear needles.

The U.S. Food and Drug Administration (FDA) has approved the first needle-free treatment for anaphylaxis , severe allergic reactions that can be triggered by certain foods , medicines, and insect stings .

The epinephrine nasal spray, called Neffy, offers an alternative to EpiPen injections and is approved for adults and children who weigh at least 30 kilograms (about 66 pounds), said the FDA in a statement . Neffy can be administered with a single dose sprayed into one nostril, followed by a second dose in the same nostril if symptoms worsen or fail to improve, according to the FDA.

"Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections," said Kelly Stone, MD, PhD, the 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," Dr. Stone said. "As a result, Neffy provides an important treatment option and addresses an unmet need."

What Is Anaphylaxis?

Anaphylaxis is a severe, life-threatening allergic reaction that typically involves multiple parts of the body and is considered a medical emergency, according to the FDA. It's most often triggered by exposure to certain foods, medicines, insect stings, or latex.

Symptoms come on rapidly, and can include hives, swelling, itching, vomiting, difficulty breathing, and loss of consciousness, according to the FDA. Epinephrine is the only lifesaving emergency treatment for anaphylaxis , and has long been used to manage symptoms until patients can receive any needed medical care.

Neffy appears to work as well as injected epinephrine. In studies of 175 healthy adults without anaphylaxis, researchers compared the safety and effectiveness of Neffy to traditional injected epinephrine. Scientists found both the inhaled and injected versions of epinephrine resulted in similar levels of this medicine in the blood and comparable improvements in heart rate and blood pressure - two things that can decrease dangerously when people experience anaphylaxis, according to the FDA. Studies also determined that blood concentrations of epinephrine in children weighing more than 66 pounds were similar to those of adults who received Neffy.

Neffy Nasal Spray Has Some Side Effects

Some of the most common side effects with Neffy include throat irritation, tingling nose, headache, nasal discomfort, feeling jittery, tingling sensation (paresthesia), fatigue, tremor, runny nose (rhinorrhea), itchiness inside the nose, sneezing, abdominal pain, gum pain, numbness in the mouth, nasal congestion, dizziness, nausea and vomiting, according to the FDA.

Neffy isn't for everyone, the FDA notes. It comes with a warning that certain nasal conditions, such as nasal polyps or a history of nasal surgery, can make this inhaled medicine less effective than injected epinephrine.

Even so, Neffy provides a welcome alternative to injected epinephrine that may make it easier for more people to use this emergency medical treatment when they need it, says Kathy Przywara , the vice president of community at the Asthma and Allergy Foundation of America.

"Nasal epinephrine spray may remove some of the barriers that prevent people from using epinephrine," Przywara says. "The needle-free device removes the fear of needle-based injections and may be easier to use. This may increase confidence among people managing life-threatening allergies."

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Sources

1. FDA Approves First Nasal Spray for Treatment of Anaphylaxis. U.S. Food and Drug Administration . August 9, 2024.

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Lisa Rapaport

Author

Lisa Rapaport is a journalist with more than 20 years of experience on the health beat as a writer and editor. She holds a master's degree from the UC Berkeley Graduate School of Journalism and spent a year as a Knight-Wallace journalism fellow at the University of Michigan. Her work has appeared in dozens of local and national media outlets, including Reuters, Bloomberg, WNYC, The Washington Post, Los Angeles Times , Scientific American , San Jose Mercury News , Oakland Tribune , Huffington Post, Yahoo! News, The Sacramento Bee , and The Buffalo News . See full bio See Our Editorial Policy Meet Our Health Expert Network