In a groundbreaking development for individuals with severe allergies, the U.S. Food and Drug Administration (FDA) has approved Neffy®, the first-ever epinephrine nasal spray for anaphylaxis, developed by ARS Pharmaceuticals.
What is Neffy®?
Neffy® is the first epinephrine nasal spray to receive FDA approval in the United States, marking a significant advancement in treating severe allergic reactions. Prior to this, epinephrine auto-injectors, which have been the standard treatment for anaphylaxis since 1987, were the only available option. The new nasal spray provides a needle-free alternative, making it an attractive choice for both adults and children weighing at least 66 pounds.
How Does Neffy® Work?
A Neffy® prescription includes two single-dose nasal spray devices. Each device delivers a 2 mg dose of epinephrine into one nostril. If symptoms do not improve or worsen after the first dose, a second dose using a new device can be administered in the same nostril. In some cases, further emergency treatment may be required.
Epinephrine is the primary treatment for anaphylaxis, as it is the only medication capable of halting the life-threatening effects of a severe allergic reaction.
Benefits of Epinephrine Nasal Spray for Anaphylaxis
The approval of Neffy® represents a major advancement in anaphylaxis treatment, offering several key benefits. Many individuals with severe allergies hesitate to use epinephrine auto-injectors due to the fear of needles. This hesitation can delay treatment, increasing the risk of severe outcomes. Neffy® eliminates this barrier by providing a needle-free alternative, potentially reducing delays in treatment and improving patient outcomes.
Lynda Mitchell, CEO of Allergy & Asthma Network, emphasized the significance of this new treatment option: “We are very pleased the FDA approved Neffy® as a safe, efficient, and effective treatment option for people at risk for severe allergic reactions. The epinephrine nasal spray gives people more choice to use the epinephrine treatment they want when they need it.”
Patient Preferences for Epinephrine Nasal Spray
Recent studies highlight a strong preference for needle-free epinephrine delivery methods. In 2018, Allergy & Asthma Network conducted a survey involving 372 patients and caregivers. The findings revealed that:
- 91% of participants would consider using an epinephrine nasal spray instead of an auto-injector.
- 72% would prefer the nasal spray over an auto-injector.
- 82% favored a needle-free option.
- 80% were more likely to carry a smaller, more discreet epinephrine product.
- 43% disliked the idea of injecting a needle to administer epinephrine.
Is Neffy® Safe and Effective?
The FDA’s approval of Neffy® was based on data from four clinical studies involving 175 healthy adults. These studies measured the concentration of epinephrine in the blood after administering Neffy® compared to an epinephrine auto-injector. Results showed that Neffy® produced comparable epinephrine levels, as well as similar increases in blood pressure and heart rate—two critical effects needed to treat anaphylaxis.
A separate study in children over 66 pounds confirmed that epinephrine levels were consistent with those observed in adults. Side effects reported during clinical trials were generally mild, with no serious adverse events. Common side effects included throat irritation, tingling in the nose, nasal congestion, sneezing, and headache.
Who Should Consider Neffy®?
While Neffy® offers a convenient alternative to auto-injectors, it may not be suitable for everyone. The FDA has issued a warning that individuals with nasal polyps or a history of nasal surgery should consult their healthcare provider before using Neffy®. Clinical trials also showed that individuals with allergic rhinitis symptoms, such as nasal congestion, achieved similar epinephrine levels as those without congestion.
Cost and Accessibility
ARS Pharmaceuticals is committed to making Neffy® accessible and affordable. For those with private health insurance that covers Neffy®, the cost is $25 per prescription through a co-pay savings program. For uninsured individuals or those with high out-of-pocket costs, Neffy® is available for $199 via BlinkRX, a digital pharmacy. Additionally, eligible U.S. residents who are uninsured or underinsured may receive Neffy® at no cost through the ARS Pharma Patient Assistance Program (PAP).
Future Epinephrine Treatments
The approval of Neffy® is just the beginning. Bryn Pharma is also developing an epinephrine nasal spray known as NDS1C, which has shown positive results in clinical trials. Additionally, Aquestive Therapeutics is developing Anaphylm™, a sublingual epinephrine strip that dissolves under the tongue, offering another needle-free option for anaphylaxis treatment.
Conclusion
The introduction of Neffy® as the first epinephrine nasal spray for anaphylaxis marks a significant step forward in the treatment of severe allergic reactions. By providing a needle-free, easy-to-use alternative to traditional auto-injectors, Neffy® has the potential to improve patient outcomes and reduce the hesitation associated with administering life-saving treatment. As more needle-free epinephrine options continue to emerge, individuals with severe allergies can look forward to greater flexibility and accessibility in managing anaphylaxis.