If you or a loved one manages a life-threatening allergy, you’re familiar with the constant need to carry an EpiPen or Auvi-Q to prevent anaphylaxis. These injectable epinephrine devices are essential for emergency situations but can be intimidating to use. Thankfully, there’s now a needle-free alternative: Nasal Spray.
What is Neffy?
For the first time, the FDA has approved a non-injection form of epinephrine—neffy. This single-dose nasal spray is designed for use in one nostril and has been approved for both adults and children weighing at least 66 pounds who suffer from severe life-threatening allergy.
FDA’s Perspective on Neffy
Dr. Kelly Stone, Associate Director of the Division of Pulmonology, Allergy, and Critical Care at the FDA, highlights the importance of this new option. “Anaphylaxis is a serious, life-threatening allergy condition. Some individuals, particularly children, might avoid or delay treatment due to fear of injections. The introduction of neffy could lower these barriers and facilitate quicker treatment, addressing a significant need in allergy management.”
A Historic Development in Allergy Treatment
Epinephrine has been the cornerstone of anaphylaxis treatment since the early 1900s, with injectable forms becoming the standard over the last 35 years, according to ARS Pharmaceuticals, the maker of neffy. For those with needle phobia, neffy represents a major breakthrough.
Clinical Trials and Efficacy of Nasal Spray
“This approval is a pivotal moment for people with Type I allergies,” said Richard Lowenthal, Co-Founder and CEO of ARS Pharmaceuticals. “A treatment that avoids needles can significantly reduce anxiety and make epinephrine more accessible and user-friendly.”
The approval of neffy was supported by four studies involving 175 healthy adults. These studies compared the epinephrine levels in the blood after using neffy to those from traditional injection products. The results showed that neffy delivered comparable levels of epinephrine, with similar effects on blood pressure and heart rate—key factors in anaphylaxis treatment.
Additionally, a study focusing on children weighing over 66 pounds confirmed that epinephrine levels from neffy were similar to those observed in adults using the same spray.
Usage and Warnings
If symptoms persist or worsen, a second dose of neffy may be necessary. As with injectable epinephrine, it’s crucial to seek emergency medical assistance for further monitoring and potential additional treatment.
Neffy does come with specific warnings. Individuals with nasal issues like polyps or a history of nasal surgeries should consult with a healthcare provider, as these conditions might affect medication absorption. The product also includes cautions for certain pre-existing conditions and potential allergic reactions to sulfites.
Potential Side Effects
Common side effects of neffy may include throat irritation, nasal discomfort, headache, and a jittery feeling, among others.
Availability and Cost
Neffy is expected to be available within eight weeks of FDA approval. It will likely cost around $25 for those with insurance, thanks to a co-pay savings program offering two single-use devices.
Impact on Allergy Management
Experts believe that neffy will enhance access to epinephrine, especially in places where accidental exposures are more likely, such as restaurants, airplanes, and hotels. Dr. Sung Poblete, CEO of FARE, a nonprofit supporting those with food allergies, describes this as a significant win for the allergy community.
The FDA’s approval of neffy is a significant advancement in allergy treatment, particularly for those who fear injections.
Dr. Jonathan Spergel, Chief of the Allergy Program at Children’s Hospital of Philadelphia, underscores the importance of this development: “Experiencing or witnessing an anaphylaxis reaction is stressful. Delays in administering epinephrine can be dangerous, especially when a needle is involved. Neffy offers an effective, non-injection option that could improve response times and overall safety.”
