‘A game changer’: TN allergy specialist reacts to FDA approving anaphylaxis nasal spray

NASHVILLE, Tenn. (WKRN) – On Friday, the Food and Drug Administration (FDA) approved a nasal spray as a needle-free alternative to injectable devices like the EpiPen for the emergency treatment of allergic reactions.

The epinephrine nasal spray, called Neffy, made by ARS Pharmaceuticals Inc., was given the green light by U.S. health officials for life-threatening anaphylaxis in children and adults who weigh at least 66 pounds.

According to the FDA, anaphylaxis is a severe allergic reaction commonly induced by certain foods, medications and insect stings. The agency said epinephrine is the only life-saving treatment for the hypersensitivity disorder.

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Food Allergy Research & Education said that 33 million Americans have at least one food allergy. The 501(c)(3) charitable organization finds that every 10 seconds, a food allergy reaction sends a patient to the emergency room in the U.S.

“The approval represents the first significant innovation in the delivery of epinephrine in more than 35 years,” ARS said.

Dr. Stokes Peebles, an allergy and pulmonary specialist at Vanderbilt University Medical Center, referred to Tennessee as the epicenter of the potentially fatal allergic condition called alpha-gal syndrome (AGS), also known as red meat allergy.

In a 2022 study conducted in Nashville by the American College of Allergy, Asthma and Immunology, the prevalence of AGS in high-risk Middle Tennessee patients was 51.75%.

“Hopefully, they’ll avoid eating the meat, but if they are exposed to it, or eggs or milk or any food allergy, I think that they’re going to be able to use [ Neffy ] more quickly, and it probably is going to save some lives,” Peebles said.

The Centers for Disease Control and Prevention reports that from 2010 – 2022, there were more than 110,000 suspected cases of AGS identified. However, the agency said because the diagnosis requires a positive diagnostic test and a clinical exam, and some individuals may not get tested, it’s estimated that as many as 450,000 people might have been affected by AGS across the country.

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Peebles said Neffy is a great advance and believes it will revolutionize the treatment of anaphylaxis in his patients and others across the nation.

“This is a real game changer,” Peebles said. “People will develop hives, they’ll develop low blood pressure, they’ll have trouble breathing, and epinephrine reverses all of that. Now, we have a medicine that can be used intranasally. They don’t have to check themselves. It’s easier to carry around with them and they can put it in their pocket without difficulty, so I think people are more likely to use it more often when it’s necessary.”

ARS expects Neffy to be available in the U.S. within eight weeks.

For more information, visit Neffy’s website .

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