Medscape - Promise of Needle-Free Epinephrine

[GoingNuts]

The Promise — and Price — of Needle-Free Epinephrine
Lara Salahi
August 28, 2025
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After Kate Sambuco's 11-year-old son, Cole, was diagnosed with allergies to peanuts, tree nuts, and dairy, she found a source of ongoing anxiety was the delivery method necessary to treat his episodes of anaphylaxis: a needle.


"Using the needle is just traumatic," said Sambuco, of Wayland, Massachusetts, who relied on epinephrine injections for these episodes. "When a kid goes into anaphylaxis, there's so much panic already. A needle is painful — and it just adds stress to an already stressful situation."

So when she heard from another parent that the FDA had approved a needle-free epinephrine nasal spray in September 2024, she immediately asked her son's allergist if the product might be an option for her son.

"It gives Cole a way to protect himself without the trauma of the needle — and that gives me peace of mind," she said. "You can use it a lot faster than a pen, and there's less hesitation."


Sambuco's experience highlights the early reception of neffy, the first FDA-approved nasal spray delivering epinephrine. While uptake is growing for the needle-free option to treat anaphylaxis, questions remain about whether some families can afford it as retail prices vary and insurance coverage has been uneven, especially for those on Medicaid and Children's Health Insurance Program.



Uptake and Early Impressions

Unlike traditional auto-injectors, which are roughly 5-6 in long and about the size of a thick marker (with two-packs weighing close to a half- lb), neffy comes in a slim case about the size of a credit card and weighs less than two ounces. A smaller auto-injection option is closer in size to a deck of cards but not as slim as neffy.

photo of Payel Gupta
Payel Gupta, MD
Payel Gupta, MD, an assistant clinical professor at SUNY Downstate Medical Center and Mount Sinai Hospital in New York City, said she has begun prescribing neffy for patients more comfortable with a nasal spray method.


"The response from patients, especially those with needle anxiety or families of younger children, has been overwhelmingly positive," said Gupta, who is also a spokesperson for the Allergy & Asthma Network.

Gupta said the smaller profile of the nasal spray has made teens more willing to carry it than the injectors.

"Teens are more open to carrying it consistently because of its size and it being needle-free. It's definitely helping reduce emotional barriers tied to epinephrine use," she said.


John Lee, MD, clinical director of the Food Allergy Program at Boston Children's Hospital, Boston, agreed portability is a major draw. Heat tolerance and longer shelf life are also major advantages. Neffy can withstand a few days of storage at up to 122 °Fand typically lasts between 24 and 30 months before expiring. EpiPen requires room-temperature storage and has a shelf life of 12-18 months.

"That matters for kids at camp or out playing sports," Lee said.

Market Momentum, Especially Among Kids

Clinicians' reports line up with early market data. Children and young adults were mostly prescribed neffy — prescribing rates were highest among those aged 0-17 years (27.78 visits per 100,000) and 18-25 years (23.01 per 100,000).


Meanwhile, prescriptions for EpiPens and Auvi-Q, a smaller auto-injection option, declined. Prescriptions for EpiPen declined by 31% in November 2024, 17% in December, and 15% in January. Prescriptions for Auvi-Q dropped by 27% in January before a modest 7% rebound in May.


Most neffy users had commercial insurance, with far lower uptake among patients on Medicare or Medicaid, according to Komodo Health, a healthcare technology company that holds a database of more than 330 million US patients from Medicare, Medicaid, and commercial insurers' medical, pharmacy and laboratory claims.

Cost Remains a Hurdle for Some

Despite enthusiasm, cost remains a sticking point. Neffy's retail price varies widely, from $199 at some pharmacies for a two-pack to over $700 based on the manufacturer's list price before insurance or discounts. In contrast, two-packs of EpiPens run around $600 at full price, and generic epinephrine injections are priced significantly lower.


"Insurance coverage has been mixed so far," Gupta said. "Commercial plans have generally started to cover it, most times with prior authorization like most meds nowadays."

Lee noted that cost can be a deciding factor.

"Some families are excellent with avoidance and haven't needed to use epinephrine in years, so they're hesitant to spend more on something they might not use," he said.


Neffy's manufacturer, ARS Pharmaceuticals, offers a copay card that can reduce out-of-pocket costs to $25 for those with commercial insurance, but the program does not apply to government-sponsored plans. The company said 19 major insurers — including UnitedHealthcare, Cigna, and Tricare — now cover the nasal spray, with varying requirements.

Clinical Support and Safety Monitoring

A phase 3 trial funded by ARS Pharmaceuticals found the nasal spray resolved moderate allergic reactions in pediatric patients within minutes and with no second dose needed.

The study, published in The Journal of Allergy and Clinical Immunology: In Practice, included 15 children between ages 6 years and 17 years who were experiencing moderate allergic reactions during an oral food challenge and were treated with weight-appropriate doses of neffy. Symptoms began resolving within 5 minutes, and no second dose of epinephrine was needed during the initial reaction. The median time to symptom resolution was 16 minutes, the study found.


"In terms of impact on anaphylaxis preparedness, I do think neffy is helping shift the landscape," Gupta said. "It's increasing options and patient comfort, which are both critical for real-world adherence."

Still, experts caution that enthusiasm should be tempered with careful monitoring as the product reaches more patients.

"As with all newly approved medications, as neffy is used in a broader population, the FDA will use post-marketing surveillance to monitor real-world effectiveness and safety, and to identify rare or unanticipated adverse events," said Julie Flom, MD, an allergist and immunologist at Yale Medicine and assistant professor at Yale School of Medicine in New Haven, Connecticut.


Flom said the FDA will likely pay particular attention to "impacts on nasal mucosa, as well as overall safety and efficacy."

The FDA Adverse Events Reporting System lists 34 reports of adverse events related to medication since the product launch. A majority of the cases involved nasal pain and discomfort. More serious cases included one case of "cardiac discomfort" and one case of anaphylactic reaction.

Flom said certain groups were underrepresented in trials and deserve further study, including "patients with anatomical nasal abnormalities like polyps or prior surgery, children under age 4, elderly patients, and those with specific comorbidities."


Misuse is another concern.

"Patient education is critical," she said. "Clinicians should review indications for use, demonstrate proper technique, and have the patient teach back using a trainer. We recommend that patients carry two devices at all times because a second dose is needed in up to 18% of episodes of anaphylaxis."

Flom also recommended that anyone who is prescribed neffy would receive guidance materials that they can take home to review proper use.


The FDA expanded approval of its original indication in March 2025 to include a 1 mg dose for children weighing 33-66 lb. ARS's "neffyinSchools" initiative has shipped free doses to over 1000 US schools. But only five states currently allow nasal epinephrine spray in emergency medication policies in schools.

Gupta said she hopes more states will allow the sprays soon.

"The ease of use, especially in public or school settings, is also a huge advantage," Gupta said. "Looking ahead, I do see nasal alternatives potentially becoming first-line for many patients,"


Lee reported being a study investigator for a Phase 4 clinical trial for neffy. Gupta and Flom reported no relevant conflicts of interest.

Lara Salahi is a health journalist based in Boston.

[hezzier]

First thing...off topic, the woman at the beginning being quoted lives in the town I grew up in.

DS has Neffy...he's a college student so having a device that isn't going to degrade due to heat or cold is essential!  And that they have a longer shelf life is important as well.

[GoingNuts]

New research on Neffy, from Medscape:


Sniffing During Neffy: Epinephrine Still Effective
Kaitlin Sullivan
November 12, 2025
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Summarize This Article
Epinephrine nasal spray works well even if patients sniff while using it, according to an abstract presented at the American College of Allergy, Asthma, and Immunology (ACAAI) 2025 Annual Meeting in Orlando, Florida.


The FDA last year fast-tracked approval of the first nasal epinephrine (neffy). The spray offers patients an alternative to injectable epinephrine pens, but because it is still a new device, "people still have a lot of questions," said Jonathan Spergel, MD, PhD, chief of the Allergy Section at Children's Hospital of Philadelphia, Philadelphia, who led the study.

One of those questions is whether sniffing during or after administering nasal epinephrine would alter the efficacy of the drug. Because patients in clinical trials did not sniff while using neffy, patient instructions advise patients against sniffing during or after a dose.

"That's a natural reaction when people do a nose spray, to sniff," Spergel said. "People were concerned about whether that was going to affect how well the drug works."


Spergel and his team recruited 42 adults for a phase 1, single-dose, randomized crossover study. Each patient sprayed 2 mg of nasal epinephrine into their nostril at a doctor's office and was filmed so the researchers could confirm whether they sniffed while taking the spray. Of the 42 participants, 29 sniffed and 12 did not sniff. Clinicians took plasma samples after each dose, which were tested to determine participants' concentration of plasma epinephrine.

Taking intranasal epinephrine without sniffing resulted in a slightly higher average maximum epinephrine plasma concentration (484 pg/mL; coefficient of variation [CV], 67%), but the difference was not statistically significant compared with people who sniffed (382 pg/mL; CV, 67%).

In a second part of the study, patients received a 0.3 mg injection of intramuscular epinephrine. The average plasma concentration was slightly lower than it was when people sniffed intranasal epinephrine (322 pg/mL; CV, 65%).


Both options work well, Spergel said, "sniff or no sniff."

The findings are welcome news for patients, said Ruchi Gupta, MD, MPH, founding director of the Center for Food Allergy & Asthma Research at Northwestern University and Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago.

"People get apprehensive when there is a new device, so the more data we have, the better," Gupta said.


Although the study was conducted in adults, the results likely apply to kids, who could especially benefit from needleless options for epinephrine, she said. Gupta has experience with nasal epinephrine, both through her patients and with her own daughter.

"She's used both the autoinjector and the nasal spray, and there was a pretty equivalent reaction," she said.

The study was funded by ARS Pharma, the makers of neffy. Spergel reported receiving grant support from and consulting on trial development for ARS Pharma.