Skip to main content

FDA Wants More Data on Neffy, First Needle-Free Antidote for Severe Allergic Reactions

Medically reviewed by Drugs.com.

By Denise Mann HealthDay Reporter

WEDNESDAY, Sept. 20, 2023 -- In a surprising move, the U.S. Food and Drug Administration (FDA) has opted not to approve a needle-free alternative to the EpiPen for emergency treatment of severe allergic reactions.

Approval of the Neffy nasal spray was widely anticipated. An FDA advisory panel voted to recommend approval of the drug for children and adults in May. While the FDA is not obligated to follow the advice of their advisory panels, it usually does.

Instead, the FDA told the drug’s maker, ARS Pharmaceuticals, that it needed to conduct another study on the drug before it is approved, the company said in a statement late Tuesday night.

"We are deeply disappointed that this action further delays the availability of Neffy for the millions of people who are at risk of a potentially life-threatening severe allergic reaction," said Richard Lowenthal, co-founder, president and CEO of ARS Pharma.

"We stand by the totality of the Neffy data package in a comprehensive registration program that was aligned upon with FDA and believe strongly in the value Neffy can provide for patients, families and caregivers living daily with severe allergic reactions," he said in a company statement, adding that his firm will aim to complete the requested trial as soon as possible.

The news was unwelcome on the front lines of health care.

“It’s certainly disappointing as we were hoping to have another option for people at risk of severe allergic reactions," said Dr. Scott Sicherer, director of the Elliot and Roslyn Jaffe Food Allergy Institute at Mount Sinai in New York City.

Both Neffy and EpiPen deliver epinephrine, which works by relaxing the muscles in the airways. Neffy is a nasal spray, while EpiPen is given as an injection into a big muscle, such as the thigh.

During an anaphylactic reaction, symptoms such as trouble breathing and swallowing, hives, nausea and vomiting can come on suddenly when a person is exposed to a triggering food, medication or insect sting. Administered quickly, epinephrine can stop this potentially fatal cascade of symptoms.

“Neffy would have been the first needle-free option for patients to treat severe allergic reactions, but we still have the injectable epinephrine devices available,” said Dr. Payel Gupta, an assistant clinical professor at SUNY Downstate Medical Center in New York City and volunteer medical spokeswoman for the American Lung Association. “A needle-free option would be great for people with needle phobia or who are anxious about injecting themselves.”

The bottom line is that having epinephrine available is vital.

“Epinephrine is a lifesaving medication and every patient who has a [history of potentially severe] allergy needs to carry the device at all times," Gupta said. “Experts recommend carrying two EpiPens as sometimes one dose isn’t enough."

Sicherer agreed.

If you think you are experiencing an allergic reaction, use your epinephrine device, he said.

“Do not wait for trouble breathing or passing out,” Sicherer said. “The medication is safe, effective and while it may cause a tiny ouch, it could be lifesaving.”

Sources

  • Scott Sicherer, MD, director, Elliot and Roslyn Jaffe Food Allergy Institute, division chief, allergy and immunology, Department of Pediatrics
  • Mount Sinai Health System, New York City
  • Payel Gupta, MD, assistant clinical professor, SUNY Downstate Medical Center, New York City, volunteer medical spokeswoman, American Lung Association
  • ARS Pharmaceuticals, news release, Sept. 19, 2023

Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

© 2024 HealthDay. All rights reserved.

Posted September 2023

Read this next

For Parents of Kids with Food Allergies, Social Media Can Bring Support -- and Stress

WEDNESDAY, May 1, 2024 -- Having a child with food allergies isn't easy to manage, and now new research shows that most of these parents turn to social media for medical...

Watchdog Group Says U.S. Food Recalls Rose Again Last Year

THURSDAY, April 25, 2024 -- U.S. recalls of foods for salmonella, foreign objects or undeclared allergens are rampant nowadays and the highest they've been since 2020, a watchdog...

Planning Safe Summer Camp Fun for Kids With Allergies & Asthma

SATURDAY, April 13, 2023 -- Preparing a kid for summer camp is already a daunting task, and it’s even more complicated if your child has allergies or asthma, experts...

More news resources

Subscribe to our newsletter

Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.