EpiPen gets a new competitor: FDA approves anaphylaxis nasal spray

Good news for those who suffer from severe allergic reactions: a nasal spray containing epinephrine rather than a needle can now treat those frightening moments.

The treatment, called Neffy, was approved on Friday after the Food and Drug Administration (FDA) denied its approval last year despite solid recommendations from the advisory committee. Neffy will become the first non-needle treatment for severe reactions, including anaphylaxis. For those who are needle-phobic, it’s a long-awaited improvement. 

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

“Anaphylaxis is life-threatening, and some people, particularly children, may delay or avoid treatment due to fear of injections,” Kelly Stone, associate director of FDA’s division of pulmonology, allergy, and critical care, said in a statement. “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.” 

Epinephrine has been the go-to treatment for severe allergic reactions since 1901. EpiPen, the pen that could quickly deliver the medication at home or on the go, was developed in the 1970s and was first used in the military. Neffy’s approval is the first significant development for epinephrine since.

According to the FDA’s announcement, Neffy is meant to be used as “a single dose nasal spray administered into one nostril.” Similar to injection products, “a second dose (using a new nasal spray to administer neffy in the same nostril) may be given if there is no improvement in symptoms or symptoms worsen.”

Neffy does have some warnings, particularly for those who have nasal conditions or a history of nasal surgery. People with those issues should consult a healthcare provider before use. Side effects can include throat irritation, headaches, dizziness, nausea and vomiting, and more.

EpiPen prices have soared in recent years, and generic brands have already been successful competitors, as they’re far more affordable. This new treatment option should help combat sky-high prices on drugs that treat allergic reactions, and anaphylaxis even more.

ARS said it will use a copay savings program to limit the cost to $25 per prescription of two Neffy devices for those with insurance. For those without, it will offer a price of $199 for two doses of Neffy through the digital pharmacy BlinkRx.