Editor's note: This story has been updated to include details on availability and pricing.
Aug. 9, 2024 – An epinephrine nasal spray to treat serious allergic reactions may soon be available in the U.S.
The FDA announced its approval of the nasal spray, called neffy, on Friday. It's for adults, and for children who weigh at least 66 pounds, who have what are known as type 1 allergic reactions, which include the potentially life-threatening condition called anaphylaxis. Signs are trouble breathing or swallowing, skin symptoms like hives and swelling, stomach problems like cramps or nausea, and heart issues like a drop in blood pressure and rapid heartbeat.
Allergic reactions are triggered by an abnormal immune system response, usually to something like food or medication, or from an insect sting. Until now, the only treatment for anaphylaxis was an epinephrine shot in the thigh, usually through an automatic injector pen like the EpiPen. Up to 2% of people in the U.S. are estimated to have a lifetime chance of having anaphylaxis.
Neffy's manufacturer, ARS Pharma, said it expects the drug to be available within 8 weeks. For patients with commercial insurance, neffy will cost $25 for two, single-use devices. For those without insurance or whose insurance won't cover neffy, ARS will offer it for a cash price of $199. Those without insurance who have exhausted all other options could receive it at no cost, the company said in a statement.
Neffy is taken as a single dose sprayed into one nostril, and a combination of four studies among 175 healthy adults showed the product could achieve a blood epinephrine level similar to what you'd get from a shot, as well as a similar increase in blood pressure and heart rate. In a study of children weighing more than 66 pounds, blood concentration levels after taking neffy were similar to levels seen in adults who used the product.
When a person’s blood pressure drops too low, they can go into anaphylactic shock, and swollen bronchial tissue can lead to loss of consciousness. Life-saving treatment is needed right away in cases of anaphylactic shock.
People with some nasal conditions or a history of nasal surgery should talk to a health care professional about whether they should use neffy, the FDA advised, and the product also may not be safe for some people with certain other conditions or sulfite allergies.
A previous announcement from ARS Pharma about its efforts to get neffy FDA-approved emphasized the importance of offering a needle-free treatment option.
“While epinephrine autoinjectors have been shown to be highly effective, there are well published limitations that result in many patients and caregivers delaying or not administering treatment in an emergency situation,” the company said.
Those limitations include a fear of needles, lack of portability, safety concerns, and more.
The company said there are about 40 million people in the U.S. who have type 1 reactions, and last year, only 3.2 million of them had a prescription for a epinephrine injection pen.
“Even if patients or caregivers carry an autoinjector, more than half either delay or do not administer the device when needed in an emergency,” the company said.
