Immediate Impact: Nasal Epinephrine Spray After Allergen Challenge
A panelist discusses how FDA bracketing studies demonstrated that Neffy's pharmacokinetics and pharmacodynamics fall within the established safety and efficacy range of existing epinephrine auto-injectors, with rapid onset within one minute.
Technology and Clinical Evidence for Intranasal Epinephrine
Neffy utilizes three well-established, FDA-approved components to deliver epinephrine intranasally. The active ingredient remains epinephrine, proven effective for anaphylaxis treatment for over a century. The key innovation lies in Intravail, a food-grade absorption enhancer that temporarily loosens tight junctions between nasal epithelial cells, allowing efficient epinephrine absorption across nasal mucosa even at relatively low doses while limiting dose-dependent side effects.
The delivery device is a small plastic nasal sprayer already used in seven other FDA-approved medications including Narcan for opioid overdoses, anti-seizure medications, and migraine treatments. This established technology provides reliable medication delivery through a familiar, proven mechanism. The combination of these three components creates a comprehensive intranasal epinephrine delivery system.
FDA approval required bracketing studies demonstrating that Neffy's pharmacokinetics and pharmacodynamics fall within the range established by existing epinephrine auto-injectors. The 2mg intranasal dose showed epinephrine blood concentrations bracketed between the upper safety limit (EpiPen 0.3mg) and lower efficacy threshold (manual syringe injection), confirming therapeutic equivalence. Ethical considerations prevent direct anaphylaxis induction studies, making bracketing studies the appropriate regulatory pathway for approval.
