EpiPen gets new competitor: FDA approves anaphylaxis nasal spray

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Good news for those with severe allergies: a nasal spray with epinephrine rather than a needle can now treat those scary moments.

The treatment, called Neffy, was approved on Friday after the Food and Drug Administration (FDA) denied approval last year despite strong recommendations from an advisory committee. Neffy will be the first needle-free treatment for severe reactions, including anaphylaxis. For those who are need-phobic, it is a long-awaited development.

Neffy is from ARS Pharmaceuticals and is approved for use in adults and children weighing more than 66 pounds.

“Anaphylaxis is life-threatening, and some people, especially children, may take or avoid treatment due to fear of injection,” said Kelly Stone, associate director of the FDA’s division of pulmonology, allergies, and critical care, in a statement. “The availability of epinephrine nasal spray may reduce the barriers to prompt treatment of anaphylaxis. As a result, Neffy provides an important treatment option and addresses an unmet need. ”

Epinephrine has been a treatment for severe allergic reactions since 1901. The EpiPen, a pen that can quickly deliver medication at home or on the go, was invented in the 1970s and first used in the military. Neffy’s approval is the first significant development of epinephrine since then.

According to the FDA’s announcement, Neffy is intended to be used as a “single-dose nasal spray in one nostril.” Similar to injectable products, “a second dose (using a new nasal spray to deliver neffy in the same nostril) may be given if symptoms do not improve or symptoms worsen.”

Neffy has some caveats, especially for those with nasal conditions or a history of nose surgery. People with such problems should consult a health care provider before use. Side effects can include throat irritation, headache, dizziness, nausea and vomiting, and more.

EpiPen prices have increased in recent years, and generic brands are already competing successfully, as they are more affordable. This new treatment option should help combat the high costs of allergy medications, and even anaphylaxis.

ARS said it will use a copay savings program to limit the cost to $25 per prescription for the two Neffy devices for those with insurance. For those who don’t have it, it will offer a price of $199 for two doses of Neffy through digital pharmacy BlinkRx.

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