LANSING, Mich. (Michigan News Source) — Michigan residents who dread the jab of an EpiPen now have a reason to breathe a little easier.

On August 9, the U.S. Food and Drug Administration (FDA) approved neffy, an “epinephrine nasal spray” developed by ARS Pharmaceuticals (FDA.gov). This new treatment provides a needle-free alternative for treating anaphylaxis—a potentially life-threatening allergic reaction—making emergency allergy treatment as simple as a sniff.

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Kelly Stone, MD, PhD, Associate Director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research, discussed the significance of this approval.

“Anaphylaxis is life-threatening, and some people, particularly children, may delay or avoid treatment due to fear of injections,” Stone said. “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” (FDA.gov).

The FDA’s approval of neffy is based on multiple studies comparing the epinephrine concentrations in the blood of healthy adults who received neffy with those who received traditional epinephrine injections. The studies demonstrated that neffy produced comparable blood concentrations of epinephrine and “similar increases in blood pressure and heart rate,” critical factors in the treatment of anaphylaxis.

In terms of accessibility, ARS Pharmaceuticals has announced that neffy will be priced at $199 for two doses available through digital pharmacy platforms such as BlinkRx and GoodRx for patients whose insurance plans do not cover the medication. Additionally, commercially insured patients can obtain neffy at $25 per prescription for two single-use devices through a co-pay savings program (FOX Business).

Until now, the only life-saving treatment for anaphylaxis has been injectable epinephrine (FDA.gov). 

Manufactured by Viatris, formerly known as Mylan, the price of EpiPens soared a few years ago, with some two-packs reaching $600 for those without insurance. This price hike led to widespread public outcry and a class-action lawsuit that was settled for $264 million. In response to the backlash, Teva Pharmaceutical Industries introduced a more affordable generic version of the EpiPen for children in 2019, providing some relief to families burdened by the high costs.

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In an August 9th news release, ARS Pharmaceuticals announced that neffy should become available in the U.S. within the next two months.

“Anyone who has experienced or witnessed an anaphylaxis reaction knows it can be very stressful deciding when to inject epinephrine to themselves or a child and often delay,” Dr. Jonathan Spergel, Chief of the Allergy Program at Children’s Hospital of Philadelphia, told ARS Pharmaceuticals. “That is why the field has long pursued an effective treatment approach that does not require an injection.”