Nasal Epinephrine for Anaphylaxis: Current Availability
Yes, a nasal epinephrine spray called Neffy is now available to US consumers for emergency treatment of anaphylaxis, representing the first FDA-approved non-injectable alternative to traditional epinephrine auto-injectors. 1
Current FDA-Approved Nasal Epinephrine Product
Neffy (epinephrine nasal spray) is licensed in both the United States and Europe for adults and pediatric patients weighing at least 30 kg (approximately 66 pounds). 1 This approval marks a significant advancement in anaphylaxis treatment, as intranasal and sublingual formulations were not available in the United States or Canada during previous guideline development cycles. 2
Why This Matters Clinically
The availability of nasal epinephrine addresses several critical barriers to effective anaphylaxis treatment:
- Underuse of traditional auto-injectors is widespread, with delayed epinephrine administration associated with increased morbidity and mortality. 3, 4
- Needle-phobia and injection fears contribute to patients not carrying or using their prescribed epinephrine auto-injectors. 3, 5
- Ease of administration is improved with needle-free delivery, potentially increasing actual use during life-threatening reactions. 3
Pharmacologic Performance
The nasal epinephrine formulations demonstrate comparable or superior performance to traditional 0.3-mg auto-injectors:
- Pharmacokinetic studies show maximum plasma concentrations comparable to or higher than standard intramuscular auto-injectors, though the clinical relevance of higher peak levels remains under investigation. 3
- Time to maximum concentration is comparable to traditional intramuscular injection. 3
- Pharmacodynamic effects are comparable to or more robust than those seen with standard auto-injectors. 3
Important Clinical Caveats
Weight Restrictions
Neffy is only approved for patients weighing 30 kg or more, meaning it cannot replace auto-injectors for young children. 1 For children under 30 kg, traditional epinephrine auto-injectors (0.15 mg for 7.5-25 kg) remain the standard. 2, 6
Still Requires Emergency Care
All patients who use any form of epinephrine for anaphylaxis must still activate emergency medical services (call 911) and be transported to an emergency department, even if symptoms resolve, due to the risk of biphasic reactions. 2, 7 The availability of nasal epinephrine does not change this fundamental requirement.
Not a Replacement for All Scenarios
Intramuscular epinephrine remains the gold standard and first-line treatment recommended by all major guidelines. 2, 6 The nasal formulation provides an alternative when traditional auto-injectors are not available, not carried, or when patients refuse injectable options.
Practical Prescribing Considerations
- Patients should still be prescribed epinephrine as part of a comprehensive anaphylaxis emergency action plan that includes trigger identification, avoidance strategies, and written instructions. 2
- The nasal spray may be particularly valuable for patients who refuse to carry traditional auto-injectors due to needle fears, potentially improving overall treatment rates. 3, 1
- Multiple doses should still be available, as 7-18% of anaphylaxis patients require more than one epinephrine dose. 7, 2
Future Developments
Additional non-injectable formulations are in development, including sublingual films and transcutaneous delivery systems, though these are not yet FDA-approved. 3, 1 The regulatory approval of Neffy suggests that additional alternatives to injectable epinephrine may become available in the near future.