What is Neffy?
Neffy (epinephrine nasal spray) is the first and only needle-free treatment option approved by the U.S. Food and Drug Administration (FDA) for the emergency treatment of Type I allergic reactions, including anaphylaxis. Developed by ARS Pharmaceuticals, it offers a needle-free alternative for individuals who may experience anxiety related to injections during an emergency. It is approved for adults and pediatric patients weighing at least 15 kg (33 lbs). Specific doses are available depending on the patient's weight.
The Science Behind Neffy: How It Works
Neffy delivers epinephrine into the body via the nasal mucosa to counteract severe allergic reaction symptoms. It utilizes a special absorption enhancer called Intravail to help the epinephrine pass quickly into the bloodstream without an injection. Once absorbed, epinephrine acts like the body's natural adrenaline, triggering responses that reverse the effects of anaphylaxis.
These effects include:
- Relaxing the airways to help with breathing.
- Constricting blood vessels to raise and maintain blood pressure.
- Stimulating the heart to ensure proper blood flow.
- Reducing swelling, hives, and itching caused by the allergic reaction.
Neffy vs. Traditional Epinephrine Auto-Injectors
Feature | Neffy Nasal Spray | Epinephrine Auto-Injector (e.g., EpiPen) |
---|---|---|
Delivery Method | Needle-free nasal spray administered into one nostril. | Intramuscular injection into the outer thigh. |
Administration Anxiety | Significantly reduced anxiety for patients and caregivers with needle phobia. | Can cause significant anxiety and hesitation for those with needle phobia, potentially leading to treatment delays. |
Shelf Life | Longer, typically around 30 months. | Shorter, typically 12 to 18 months. |
Storage Temperature | More robust, tolerating a wider range of temperatures without degrading. | Must be stored at room temperature; extreme temperatures can cause degradation. |
Ease of Use | Considered easy to use, with clear instructions and no need for extensive priming. | Can be prone to operator error, though voice-guided options exist. |
Key Side Effects | Nasal discomfort, headache, throat irritation, anxiety. | Injection site pain and swelling, anxiety, jitteriness. |
Potential Limitations | Absorption could be affected by severe underlying nasal conditions like polyps or recent surgery, though studies have shown effectiveness with rhinitis. | Requires a direct, forceful injection into the muscle, which some find difficult or scary. |
How to Properly Use Neffy
Proper use of Neffy is essential. Follow these steps, which are also detailed on the product packaging and should be reviewed with a healthcare provider:
- Remove the Neffy device from its packaging. It comes in a twin pack, so always keep two available.
- Hold the device with your thumb on the bottom plunger and your fingers on the nozzle. Do not test the device, as it contains a single dose.
- Insert the nozzle into one nostril until your fingers touch your nose.
- Press the plunger firmly and quickly until it sprays.
- Avoid sniffing during or immediately after use. If liquid drips out, the full dose may not have been absorbed.
- Immediately call for emergency medical help after administering Neffy, as anaphylaxis requires professional monitoring.
- If symptoms don't improve or worsen, a second dose may be administered in the same nostril according to the product instructions.
Efficacy and Considerations
Neffy's FDA approval was supported by studies in healthy adults showing that it reached similar epinephrine levels in the blood and had comparable effects on blood pressure and heart rate as approved injectable epinephrine products. Studies also indicated effective absorption even with mild to moderate nasal congestion. While direct testing on patients experiencing severe anaphylaxis in clinical trials wasn't feasible for ethical reasons, observational data and studies in individuals with induced rhinitis support its effectiveness in real-world scenarios. However, individuals with certain nasal conditions like polyps or a history of nasal surgery should consult an allergist, as an auto-injector might be a more reliable option in such cases.
Conclusion
Neffy nasal spray is a significant new option for emergency treatment of severe allergic reactions. It provides a needle-free alternative that can ease anxiety for many patients and caregivers, potentially leading to faster administration during an emergency. While studies indicate its efficacy is comparable to injectable epinephrine, especially with growing real-world evidence, it may not be suitable for everyone. Consulting with an allergist is crucial to determine the most appropriate epinephrine delivery method based on individual needs and medical history. Visit the official FDA page for the press release regarding Neffy's approval.