New Spray For Severe Allergic Reactions

This summer, the FDA granted fast-track approval to neffy, the first nasal epinephrine spray, offering a promising alternative to injectable epinephrine for treating anaphylaxis. According to the FDA, patients often delay or avoid treatment due to fear of injections. Neffy provides an easier, needle-free option, achieving similar serum epinephrine levels, blood pressure increases, and pulse rates as intramuscular (IM) epinephrine in pharmacokinetic studies with healthy volunteers.

Neffy addresses critical challenges in anaphylaxis management. For example, a patient with fire ant anaphylaxis once accidentally injected his thumb instead of his thigh using an epinephrine autoinjector (EAI)—a mistake impossible with neffy. Tragically, hesitation in using EAI devices can also lead to fatal delays, as in a case where a parent, afraid to administer the injection, drove their child to the ER, resulting in a respiratory arrest due to traffic delays.

Hesitation isn't limited to patients. Some clinicians fail to treat anaphylaxis appropriately, opting for IV antihistamines or corticosteroids instead of epinephrine. Misunderstandings about epinephrine, perceived as a potent medication to be used sparingly, exacerbate the problem. Yet, as Dr. Gary Stadtmauer emphasizes, epinephrine is a naturally occurring hormone, with administration mimicking levels seen in stress-induced "fight-or-flight" responses.

Potential Benefits

• Reduces fear of injections, encouraging timely use by patients, families, and clinicians.
• Compact and easier to carry than larger devices.
• Prevents incorrect administration.
• Longer expiration period (8 months more than EAIs).
• No pharmacist substitutions due to its unique design.

Challenges

• Training: Unlike EAIs, no in-office training devices exist for nasal sprays. A small nasal model or a dedicated training device could enhance patient education.
• Nasal conditions: Patients with nasal polyps, surgery, or allergic rhinitis (common in food allergy patients) may experience compromised absorption. Further studies are needed to understand these effects.
• Insurance coverage: Dual prescriptions for nasal and IM devices may be necessary for severe cases, but coverage remains uncertain.

Delayed epinephrine use in anaphylaxis significantly increases mortality risk. Neffy’s needle-free design could save lives by addressing barriers to timely treatment. However, careful patient education, further research on absorption in certain populations, and insurance support will be crucial to its success.

Sources: Gary Stadtmauer, MD, via Medscape, November 6, 2024.