FDA passes on first nasal spray alternative to epinephrine autoinjectors

The Food and Drug Administration has declined to approve an alternative to epinephrine autoinjectors such as EpiPens, telling the maker of a nasal spray that more study is required.

ARS Pharma, maker of the drug, said in a statement the FDA requested completion of a study assessing the impact of repeat doses of the spray, called neffy, compared with repeat doses of epinephrine injection. The request comes despite an FDA Advisory Committee recommendation in May 2023 to approve neffy without further study.

Richard Lowenthal, co-founder and CEO of ARS Pharma, said the company would appeal the decision but would also complete the required trial as quickly as possible.

“We are very surprised by this action," Lowenthal said. "Multiple committee members highlighted the favorable profile of neffy."

About 32 million people in the U.S. have food allergies, according to Food Allergy Research and Education, or FARE, a nonprofit food allergy advocacy group. Research estimates anaphylaxis may cause up to 200 deaths each year.

Lowenthal said neffy can be easily carried and administered "without anxiety or hesitation, which is critical to stopping disease progression."

"We have heard a tremendous outpouring of support from the patient, advocacy and physician communities, who have a critical need for a needle-free epinephrine treatment," he said.

Dr. Sung Poblete, CEO of FARE, said the FDA advisory committee recommended the agency approve neffy for adults and children over 6.

"As one of the more than 33 million Americans with life-threatening food allergies, I am frustrated by the FDA’s decision today," Poblete said in a statement. "Our community believed this innovation would finally come to the more than 10 percent of Americans with life-threatening food allergies, but instead, the FDA will force us to wait even longer."

How does neffy work?

There’s no preparation or activation before using neffy, Lowenthal said. The device works similarly to Narcan, the nasal spray that reverses opioid overdoses.

“You grab the device, put it in somebody’s nose and press the plunger at the bottom of the device and it will snap and spray the medicine,” he said.

The person doesn’t need to be breathing or snort the medication, he said; it’s automatically absorbed by the nasal mucosa.

This isn't possible with normal epinephrine, which isn't absorbed in the nose if taken from a vial. But the new nasal spray has a solvent that gets between cells in the nose and helps the body absorb epinephrine.

Data presented to the FDA shows neffy performed similarly to injected epinephrine, said Dr. Corinna Bowser, an allergist and fellow of the American Academy of Allergy, Asthma and Immunology, who is not affiliated with the drug’s studies. Injected epinephrine typically produces variable results based on someone’s age, weight and body mass, she added.

“What they’re claiming is that (neffy) is not much more variable or less variable than some of the FDA-approved injectables,” Bowser said.

The most-reported side effects included mild nasal discomfort, headache, runny nose, nausea, moderate dizziness, moderate vomiting and mild throat irritation.

Nasal spray would not require training

A 2021 survey published found in the Annals of Allergy, Asthma and Immunology found epinephrine autoinjectors were underused in severe allergic reactions among young patients.

Survey respondents said they didn’t use epinephrine because they didn’t think the reaction was severe enough, it was the patient’s first allergic reaction, they used other medication or they were afraid of using an autoinjector.

Christine Creter said her 12-year-old son, Colin, must carry injectable forms of epinephrine because he has more than a dozen food allergies. A nasal spray version would be much easier to administer, she said.

"I'm so disappointed that our allergic community has to continue to wait for an alternative to an injectable form of epinephrine to save our lives," Creter said.

Health experts hope the nasal spray’s easy use means it will eventually be available in more settings: schools, airplanes and first-aid kits, among others. And unlike injected epinephrine, no training is required, Lowenthal said.

“Even if you’re trained to use the autoinjector correctly, that doesn’t mean you’ll do it correctly,” said Poblete. “I’ve heard of parents who have injected their own thumb.”

Contributing: Ken Alltucker

This article originally appeared on USA TODAY: FDA rejects first nasal spray alternative to epinephrine autoinjectors