Objective:

To provide an emergency treatment option for allergic reactions, including anaphylaxis, via a nasal spray.

Approach:

• Approval Details: The FDA approved neffy (epinephrine nasal spray) for patients weighing at least 30 kgs.
• Significance: The nasal spray may reduce treatment barriers, especially for pediatric patients who fear injections.
• Study Basis: Approval was based on 4 studies involving 175 healthy adults measuring blood epinephrine concentrations.
• Administration: The spray is a single-dose administered into one nostril, with a second dose possible if needed.

Key Findings:

• Epinephrine concentrations from the nasal spray are comparable to those from injection products.
• Similar increases in blood pressure and heart rate were observed with both administration methods.
• In children over 66 lbs, epinephrine concentrations were similar to those in adults.

Interpretation:

Limitations:

• Certain nasal conditions may affect drug absorption, requiring consultation with healthcare professionals.
• Warnings exist for patients with specific coexisting conditions and allergic reactions to sulfite.

Conclusion:

The approval of neffy provides an important alternative for the emergency treatment of anaphylaxis.

Sources:

• U.S. Food and Drug Administration