Sept. 6, 2024 – People at risk of serious allergic reactions – whether from food, medication or insect bites – could have a needle-free version of epinephrine in their pockets as soon as October.
“This could be a game changer for people hesitant to use an epinephrine auto-injector on themselves due to a fear of needles or injections,” said Melanie Carver, chief mission officer of the Asthma and Allergy Foundation of America.
In the foundation’s recent My Life with Food Allergy study, 3 out of 4 parents said their child had experienced a serious allergic reaction and didn’t use an epinephrine injection for treatment. Their top reasons were fear of the epinephrine, auto-injector, or needle.
But that could all change soon.
The FDA has approved a nasal spray , called neffy, for adults and children who weigh at least 66 pounds. The treatment, which is made by ARS Pharmaceuticals, is intended for those who have type 1 allergic reactions, including life-threatening conditions such as anaphylaxis.
Neffy represents the first needle-free option for people who need epinephrine, the first-line treatment for anaphylaxis. Until now, epinephrine has only been available through an auto-injector pen – like the EpiPen – which has caused barriers due to cost, shelf life, availability, and needles.
“Caregivers and community first responders may also have hesitation in using auto-injectors, so an easy-to-use, needle-free option could make it more likely that epinephrine is administered quickly and safely in emergency situations,” Carver said.
Who Can Use It?
Neffy was tested in adults and children weighing more than 66 pounds, so the initial product will only be available for those groups. But ARS has said it plans to ask for FDA approval for children who weigh 30-66 pounds later this year.
Although weight can vary broadly, 66 pounds is typical for kids who are ages 8-11, and the guidelines say the “adult dose” should be considered in children weighing at least 25 kilograms (55 pounds), which would be typical for ages 7-10, said David Golden, MD, an allergist in Baltimore and a member of the American Academy of Allergy, Asthma and Immunology Anaphylaxis Committee.
So far, studies don’t show that the nasal spray can’t be used by any specific groups. In fact, the data suggests it still works even when people are unconscious, Golden said.
What’s the Cost?
ARS said the cash price of a two-pack is expected to be $199 using online pharmacies such as BlinkRx or GoodRx. People with commercial insurance will likely pay $25. ARS will also offer a patient assistance program for those who don’t have other options.
What’s the Dosage?
Each package contains two single-use devices – with one dose per spray bottle. Each dose is similar to an auto-injector dose and can be repeated after 5-10 minutes (or later) if symptoms don’t improve, Golden said.
What’s the Expiration?
ARS said neffy’s shelf life is 30 months and allows for temperature exposure up to 122 F, which could allow it to be left in a car or outside. If accidentally frozen, neffy can be thawed and used.
What’s the Availability?
At FDA approval in early August, ARS estimated the nasal spray would be available in about 8 weeks. Carver said it’ll likely be late October or early November before patients can find it easily.
People are also asking about availability in other places where auto-injectors are used, such as schools and childcare facilities. Bud funding and policy issues may need to be worked out before the nasal spray can be stocked in these locations, Carver said.
The Asthma and Allergy Foundation of America and other allergy-focused groups are now reviewing state policies and encouraging state and local policymakers to look at their rules on stocking epinephrine in schools and other public places.
“We know the food allergy community is eager for more options and improved access to care,” said Sung Poblete, PhD, CEO of Food Allergy Research and Education. “We believe that a nasal spray option may make it easier to stock epinephrine at public venues, in restaurants, and at hotels for use in the event of an emergency.”
What Are the Benefits?
Overall, patients and allergy experts alike seem optimistic about a new, small device that can be carried easily and has a good shelf life. Looking ahead, it may also be “easier to teach children how to use it,” Carver said.
The convenience and ease of use could help patients, caregivers, and health care providers to feel comfortable with stocking and using epinephrine in the first place, said Paul Williams, MD, a clinical professor of pediatrics at the University of Washington School of Medicine and president of the American Academy of Allergy, Asthma and Immunology.
“One thing that happens in food allergic patients is that avoidance works well for them,” he said. “They don’t have to use their epi, so they forget how to use it and don’t carry it with them.”
What Are the Drawbacks?
Although many people are excited, Golden said, some aren’t yet ready to trust the new product, especially if they’ve used an auto-injector in the past and don’t mind using it again in the future. Others have said they’re waiting on more studies, such as real-world evidence that needle-free products work as well as “gold standard” auto-injectors.
Even so, the FDA’s approval was expected, he said, particularly given the major public outcry after the FDA advisory panel at first decided not to approve the nasal spray in 2023.
“I am relieved that neffy was approved without the need for further studies, because it is so needed,” Golden said. “Any epi product that people will use promptly is better than a product that people don’t use – more than 80% don’t use epi when they should.”
What Do the Studies Show?
Based on four studies among 175 adults and a study of children weighing more than 66 pounds, the blood epinephrine levels after neffy are considered effective and reach the same levels as with an auto-injector, as well as similar increases in blood pressure and heart rate.
At the same time, various things play a role, Golden said. For instance, “how fast” an epinephrine product works may depend on how bad the reaction is, how high the “therapeutic level” should be, and when blood levels are measured (at 5 minutes, vs. 15 minutes). Even auto-injectors may build up slower in some cases and faster in others.
“Ideally, we want the epi to build up the same in everyone for a consistent and reliable effect,” Golden said. “These are some of the concerns that will be the focus of research on all epinephrine products, current and future.”
In the meantime, neffy appears to work as well as an auto-injector, and the studies show it delivers an effective dose even if someone has nasal congestion, Carver said.
In general, epinephrine is “under-prescribed, under-utilized and delayed in use” for anaphylaxis, often in favor of other treatments such as antihistamines and corticosteroids, Williams said. A nasal spray option could “help solve a lot of the problems” seen with auto-injector availability, cost, and use, he said.
“As both a clinician and a food allergy patient, I recognize the critical role needle-free epinephrine delivery methods play in reducing injection hesitancy, which can delay life-saving treatment,” Poblete said. “This is a win for the food allergy community.”
