For decades, the EpiPen has saved countless lives as the go-to treatment for severe allergic reactions. Soon, a new nasal spray may be replacing it in certain cases.
“Anyone who has experienced or witnessed an anaphylaxis reaction knows it can be very stressful deciding when to inject epinephrine to themselves or a child and often delay,” said Dr. Jonathan Spergel, Chief of the Allergy Program at Children’s Hospital of Philadelphia, according to an Aug. 9 press release from ARS Pharma.
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That was the same day that the U.S. Food and Drug Administration approved neffy, the company’s nasal epinephrine spray, for the emergency treatment of allergic reactions, including life-threatening anaphylaxis. So far, it is approved for adult and pediatric patients who weigh at least 66 pounds.
According to the FDA, neffy is a single dose nasal spray administered into one nostril. Typically, epinephrine injection products have a second dose to administer in the case of very severe reactions. Similarly, a second dose of neffy can be administered in the same nostril.
“Patients may need to seek emergency medical assistance for close monitoring of the anaphylactic episode and in the event further treatment is required,” the FDA said.
Epinephrine (also known as adrenaline) works by relaxing the muscles the airways and tightening the blood vessels, per the National Library of Medicine. It is in a class of medications called alpha- and beta-adrenergic agonists. According to the National Inventors Hall of Fame, Sheldon Kaplan developed the design of the EpiPen, which allowed fast administration of the drug when it was first introduced in 1980.
“The approval represents the first significant innovation in the delivery of epinephrine in more than 35 years and is the first and only needle-free treatment option for patients and families living with severe allergic reactions,” said ARS Pharma of neffy’s approval.
A study presented during the 2022 American College of Allergy, Asthma and Immunology (ACAAI) Annual Scientific Meeting demonstrates why this is such an important step. It found that nearly half of adults with severe food allergies had not been prescribed an epinephrine and that 36% of adults believe epinephrine auto injectors (EAIs) can cause negative or life-threatening effects. Another study conducted last year found that only 40% of high risk patients carry their EpiPen with them.
“Given that food allergy affects more than 32 million people in the United States, we wanted to find out why more people weren’t carrying EAIs for their food allergy,” said says Jennaveve Yost, lead author of the study. “Our survey of more than 1,000 adults showed the top reported reason for not having an EAI was ‘my doctor did not indicate it was really needed’ or ‘I don’t believe I need it” – indicating that education gaps present a notable barrier to EAI access.”
Spergel also noted that the needle administration method can cause “dangerous hesitation” in patients who need epinephrine.
FDA approval for neffy was based on four studies in 175 healthy adults without anaphylaxis that showed there were comparable epinephrine blood concentrations between neffy and approved epinephrine injection products. While there is excitement about the treatment, this lack of research in patients experiencing anaphylaxis is concerning for some medical professionals, NPR reported.
“We’re very excited about this development but we do have serious concerns,” said Dr. Robert Wood, director of Johns Hopkins Children’s Center’s Division of Allergy, Immunology and Rheumatology, and a Johns Hopkins professor of pediatrics, as cited by the outlet.
NPR said that one study conducted in Japan found that the nasal spray helped calm down food allergy reactions within minutes.
Other concerns about the nasal spray compared to the injection are related to how well it can be absorbed by different people. Those with nasal polyps or a history of nasal surgery may not be able to absorb it as well as others, for example. The FDA said patients should consult their doctor about whether they are a good candidate for it.
“Neffy also comes with warnings and precautions about use of epinephrine by people with certain coexisting conditions and allergic reactions associated with sulfite,” said the FDA.
Common side effects include: throat irritation, tingling nose (intranasal paresthesia), headache, nasal discomfort, feeling jittery, tingling sensation (paresthesia), fatigue, tremor, runny nose (rhinorrhea), itchiness inside the nose (nasal pruritus), sneezing, abdominal pain, gum (gingival) pain, numbness in the mouth (hypoesthesia oral), nasal congestion, dizziness, nausea and vomiting.
ARS Pharma said allergic reactions result in an estimated 500,000 emergency room visits annually. The company said it committed to provide affordable access to the treatment. For example, it plans to limit what most commercially insured patients pay to just $25 for each filled prescription of two single-use doses of the drug.
“The price of the EpiPen has been controversial since Mylan acquired the rights to produce it in the U.S. in 2007 and increased the price by 600%,” said NPR. “On average retail prices for EpiPen range from $650 to $750, without insurance according to GoodRx. A generic version costs between $150 and $200.”
According to ARS Pharma, neffy is expected to become available within the next six weeks. When available, it will have a 30-month shelf life. EURneffy was also approved by the European Commission last week.
“In the interim, patients can visit www.neffy.com to register for product updates, including when telemedicine services will be available,” said the company.
Going forward, NPR reported that other epinephrine alternatives are in the works, including a nasal spray from ARS Pharma for smaller children.
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