Neffy FDA approval: First nasal spray for allergic reactions gets green light

The Food and Drug Administration approved a new nasal spray Friday as the first needle-free emergency treatment for potentially fatal allergic reactions.

The spray, which is made by ARS Pharmaceuticals and sold under the brand name Neffy, is seen as an alternative to EpiPen and other autoinjectors that are filled with epinephrine, a life-saving drug used by people at risk of anaphylaxis and other allergic reactions.

Anaphylaxis is a severe, life-threatening allergic reaction that typically involves multiple parts of the body and is a medical emergency. Research estimates anaphylaxis may cause up to 200 deaths each year.

Neffy, a single-dose nasal spray that can be administered into one nostril, was approved for use in adult and pediatric patients who weigh at least 66 pounds.

The Asthma and Allergy Foundation of America (AAFA) said the nasal spray may remove some barriers that prevent people from using epinephrine, especially for children who may be afraid of needles.

"The needle-free device removes the fear of needle-based injections and may be easier to use," said Kathy Przywara, community vice president at AAFA. "This may increase confidence among people managing life-threatening allergies."

Neffy's approval is based on four studies in 175 healthy adults without anaphylaxis that measured the epinephrine concentrations in the blood following the administration of Neffy or approved epinephrine injection products.

Last year, the U.S. health regulator declined to approve the spray and requested additional testing, a decision that went against the recommendation of its independent experts.

How does Neffy work?

There’s no preparation or activation necessary before using Neffy, Richard Lowenthal, co-founder and CEO of ARS Pharma, told USA TODAY last year. The device works similarly to Narcan, the nasal spray that reverses opioid overdoses .

“You grab the device, put it in somebody’s nose and press the plunger at the bottom of the device and it will snap and spray the medicine,” he said.

The person doesn’t need to be breathing or snort the medication, he said; it’s automatically absorbed by the nasal mucosa.

This isn't possible with normal epinephrine, which isn't absorbed in the nose if taken from a vial. However, the new nasal spray has a solvent that gets between cells in the nose and helps the body absorb epinephrine.

The most reported side effects included mild nasal discomfort, headache, runny nose, nausea, moderate dizziness, moderate vomiting and mild throat irritation.

Contributing: Reuters

This article originally appeared on USA TODAY: Neffy FDA approval: First nasal spray for allergic reactions gets green light