A needle-free nasal spray has been approved for severe allergic reactions to food, medications and insect bites – an alternative to the well-known EpiPen, reported the Washington Post.
The US Food and Drug Administration (FDA) approved the alternative 2-milligram spray called Neffy on Friday. It is the first needle-free treatment for allergic reactions.
According to the FDA, Neffy can treat life-threatening allergic reactions (anaphylaxis) in adults and children weighing more than 30 kilograms.
Symptoms of anaphylaxis, which usually appear within minutes of exposure, include hives, swelling, itching, vomiting, difficulty breathing and loss of consciousness, according to the FDA. Epinephrine is the only life-saving treatment for anaphylaxis, but until now it was only available to patients as an injection, according to the FDA.
“Anaphylaxis is life-threatening, and some people – especially children – delay or avoid treatment due to fear of injections,” said Dr. Kelly Stone, deputy director of the Division of Pulmonology, Allergy and Critical Care Medicine in the FDA’s Center for Drug Evaluation and Research in a press release. “Therefore, Neffy offers an important treatment option and fills an unmet need.”
The new nasal spray can be administered as a single dose into one nostril, the Post reported. The FDA said a second dose using a new Neffy device in the same nostril “can be administered if symptoms do not improve or worsen.”
Richard Lowenthal, CEO of ARS Pharmaceuticals, the maker of Neffy, said in an interview that Neffy will help people with severe allergies lead normal lives, according to the Post.
“People don’t want to inject themselves, so they wait and procrastinate,” Lowenthal said, the Post reported. Instead of worrying about a reaction at the restaurant, he said, “they have something they can use that they’re not afraid of,” according to the Post.
Neffy’s cash price will be $199 and it will come in a pack of two disposable devices, the Post reported. People with private health insurance can get Neffy after redeeming vouchers with a $25 deductible, Lowenthal said.
Neffy’s approval was based on four studies involving 175 healthy adults who did not experience anaphylactic shock, the FDA said, which found that use of the nasal spray left a comparable concentration of adrenaline in the blood as injectable products, the Post reported.
The FDA advises patients with possible nasal conditions, such as nasal polyps or a history of nasal surgery, to consult their doctor, as this may affect the absorption of Neffy.
According to ARS, Neffy is expected to be available in the U.S. within eight weeks of FDA approval.
The next challenge, according to the Post, is to make Neffy “as ubiquitous” as the EpiPen in schools, movie theaters, recreational facilities and other public areas.
Megan Swift is a TribLive reporter covering breaking news in Western Pennsylvania. A native of Murrysville, she joined the Trib full-time in 2023 after serving as editor in chief of The Daily Collegian at Penn State. Before that, she worked for three summers as a Jim Borden Fellowship intern at the Trib. She can be reached at [email protected].
