FDA moves the needle, approves first nasal spray for treatment of severe allergic reactions
ARS Pharmaceuticals receives FDA approval for nasal epinephrine treatment
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Those suffering from anaphylaxis, a severe allergic reaction that could be life-threatening, now have another treatment option following U.S. Food and Drug Administration (FDA) approval.
On Friday, the FDA announced the approval of neffy, an epinephrine nasal spray by ARS Pharmaceuticals, for emergency treatment of allergic reactions in adults and pediatric patients who weigh more than 66 pounds. The decision helps patients move away from the needle most commonly used in the brand-named auto-injector EpiPen.
"Today’s approval provides the first epinephrine product for the treatment of anaphylaxis that is not administered by injection," 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's release.
"Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections," she continued. "The availability of epinephrine nasal spray may reduce barriers to rapid treatment of anaphylaxis. As a result, neffy provides an important treatment option and addresses an unmet need."
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ARS Pharmaceuticals' neffy epinephrine nasal spray. (ARS Pharmaceuticals / Fox News)
Anaphylaxis is considered a medical emergency that patients should immediately seek medical care for. The severe, life-threatening reaction happens when a person's immune system reacts abnormally to a substance that normally does not cause symptoms. Some common allergens that could cause anaphylaxis are certain foods, medications and insect stings.
Symptoms can occur within minutes of exposure and include, but are not limited to, hives, swelling, itching, vomiting, difficulty breathing and loss of consciousness.
"Epinephrine is the only life-saving treatment for anaphylaxis and has previously only been available for patients as an injection," the FDA stated.
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A close up of an EpiPen epinephrine autoinjector. (Getty Images)
Even after being treated with epinephrine, patients are still urged to seek additional medical care.
EpiPens are currently made by Viatris, according to its website. The drug distributor was once called Mylan, FOX 5 Atlanta reports, and it just settled a class-action lawsuit for $264 million over skyrocketing EpiPen prices.
Years ago, EpiPen costs made headlines when some two-packs reached a price tag of $600 in some locations for those without insurance.
The U.S. Food and Drug Administration headquarters in White Oak, Maryland, on Aug. 25, 2020. (Stefani Reynolds/Bloomberg via / Getty Images)
In 2019, Teva Pharmaceutical Industries created a more affordable generic version of the EpiPen for children.
Neffy is expected to be available in the U.S. within eight weeks. Emergency room visits as a result of the allergic reactions it is meant to treat are estimated at 500,000, "with nearly 60% of such patients reported to not have received epinephrine prior to visiting the ER," ARS Pharmaceuticals states in a news release.
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ARS Pharma will offer neffy at a price of $199 for two doses via digital pharmacy sites like BlinkRx and GoodRx for eligible patients whose insurance plans do not cover neffy. Some commercially insured patients can access the treatment at $25 for each filled prescription of two single-use neffy devices through a co-pay savings program.
Reuters contributed to this report.