Neffy Epinephrine Nasal Spray: Is It FDA Approved?

Neffy, an epinephrine nasal spray designed to decrease severe allergic reactions and serve as an alternative to EpiPens, has officially been approved by the FDA, ARS Pharmaceuticals announced today in a press release.

The spray represents the first needle-free emergency treatment for potentially fatal allergic reactions, the FDA said in its announcement. “The availability of epinephrine nasal spray may reduce barriers to rapid treatment of anaphylaxis,” Dr. Kelly Stone, associate director of the division of pulmonology, allergy and critical care in the FDA’s Center for Drug Evaluation and Research, said in the FDA statement. “As a result, neffy provides an important treatment option and addresses an unmet need.”

Specifically, Neffy has been approved to treat Type I Allergic Reactions in adults and children who weigh 66 pounds or more. That includes anaphylaxis, a life-threatening allergic reaction that occurs when the body is exposed to an allergen and goes into shock, according to Mayo Clinic. Anaphylaxis must be treated immediately, ideally with epinephrine (aka adrenaline) and a follow-up trip to the emergency room.

The EpiPen and EpiPen Jr. (for kids), auto-injectors that contain epinephrine, were previously the only treatments available to decrease these kinds of severe allergic reactions. EpiPens inject epinephrine directly into the muscle, using a needle that many people (especially kids) find frightening and even traumatic, according to many patient and parent testimonies during the FDA’s expert advisory panel meeting on Neffy last May.

“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,” Richard Lowenthal, co-founder, president, and CEO of ARS Pharmaceuticals, said in the company’s statement.

Research has confirmed that EpiPens are underused. A 2011 study of over 14,600 patients with EpiPens found that only 11 percent refilled their EpiPen prescription “consistently at all expected refill times.” A subsequent 2021 survey on EpiPen underuse found that caregivers are often hesitant to use the injector for a number of reasons, including their own fear of the child’s reaction (about 29 percent), and the child’s fears or nerves around the needle (about 4 percent). Many patients and parents may find an epinephrine nasal spray more convenient and less frightening to use.

Neffy was originally slated for an approval decision last June, after its expert advisory panel voted to recommend the FDA approve the medication. The FDA extended its deadline to September to allow for discussions of “labeling and post-marketing requirements,” according to a June press release from ARS. Post-marketing requirements typically refer to “activities after FDA approval of a product to generate additional data about a product’s safety, efficacy or optimal use,” an ARS spokesperson told Allergic Living at the time.

Then, in September, the FDA announced it had rejected Neffy, citing the need for another study on the drug, per a statement at the time — a request ARS Pharmaceuticals announced it would appeal.

Now approved, the FDA says it analyzed four studies to make its ultimate decision. Results from the studies, which looked at 175 health adults without anaphylaxis, “showed comparable epinephrine blood concentrations between neffy and approved epinephrine injection products,” the FDA noted. A study of the medication in children showed that epinephrine concentrations were similar to those of adults who’d taken Neffy.

Neffy should be available within eight weeks, according to ARS Pharmaceuticals’ statement. As a next step, the brand says it will also seek approval for use in children from 15 to 33 kilograms (33 to 66 pounds).

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