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Act Fast: Ensuring Rapid Anaphylaxis Treatment with Intranasal Epinephrine : Episode 5

Nasal Epinephrine Spray: Review of Clinical Trial Results

June 10, 2025

Sakina S. Bajowala, MD

Opinion

Video

A panelist discusses how Neffy represents a novel intranasal epinephrine delivery system using three FDA-approved components: epinephrine, Intravail absorption enhancer, and a proven nasal spray device already used in other medications.

EP: 1.Understanding Anaphylaxis: The Signs, Symptoms, and Burdens

EP: 2.Epinephrine First: The Proven First-Line Treatment for Anaphylaxis

EP: 3.Bridging the Barriers: What is Preventing Patients From Using Epinephrine

EP: 4.An Opportunity for Innovation: Rethinking Unmet Needs in Epinephrine Administration

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EP: 5.Nasal Epinephrine Spray: Review of Clinical Trial Results

EP: 6.Immediate Impact: Nasal Epinephrine Spray After Allergen Challenge

EP: 7.Safety Solidified: Results of Oral Food Challenge Trials With Nasal Epinephrine Spray

EP: 8.A Fit for Many: Storage, Shelf Life, and Ideal Patients

EP: 9.Transitioning to the Real-World: Expert Experiences with Nasal Epinephrine Spray

Evolution of Epinephrine Devices and Introduction of Intranasal Options

The landscape of epinephrine delivery devices has evolved significantly since the EpiPen's introduction in 1987. Traditional auto-injectors including EpiPen, TwinJect, Adrenaclick, AUVI-Q, and Teva generic devices have been used interchangeably, all offering pediatric (0.15mg) and adult (0.3mg) doses with similar pharmacokinetic and pharmacodynamic profiles. These needle-based devices have established the standard of care for anaphylaxis treatment over several decades.

In 2024, Neffy emerged as the first FDA-approved intranasal epinephrine spray, representing a significant advancement in anaphylaxis treatment options. This needle-free alternative is available in two formulations: a 1mg dose for children aged 4+ weighing 15-30kg (33-66 pounds) and a 2mg dose for patients weighing 30kg or more. The weight parameters align with existing auto-injector dosing guidelines.

Traditional injectable epinephrine devices face several challenges including needle aversion, needle phobia, risk of improper injection technique, and concerns about needle length in pediatric patients. Additional barriers include limited availability in public spaces due to cost, storage requirements, shelf life concerns, and device size affecting portability. These factors contribute to reduced patient compliance and delayed treatment in emergency situations.