FDA Approves ARS’s Epinephrine Nasal Spray for Emergency Allergic Reactions

FDA Approval:
The U.S. Food and Drug Administration (FDA) has approved ARS Pharmaceuticals' epinephrine nasal spray, neffy, for the emergency treatment of allergic reactions, including anaphylaxis, in adults and pediatric patients weighing at least 66 pounds.

Needle-Free Alternative:
Neffy is the first needle-free alternative to EpiPen-style injectors, providing a critical option for individuals who fear injections.

Administration:
The nasal spray is administered as a single dose in one nostril and can be repeated if symptoms do not improve or worsen.

Clinical Studies:
Approval was based on studies showing comparable epinephrine blood concentrations and similar physiological effects to approved epinephrine injection products.

Side Effects:
Common side effects include throat irritation, nasal discomfort, headache, and dizziness.

Special Considerations:
Patients with certain nasal conditions or coexisting health issues should consult healthcare professionals before using neffy.

Fast Track Designation:
The FDA granted neffy Fast Track designation, indicating its potential to address an unmet medical need.