Medical Professionals Reference (MPR)FDA Approves Neffy, an Epinephrine Nasal Spray for Anaphylaxis

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The US Food and Drug Administration (FDA) has approved neffy®, an intranasal epinephrine spray for the emergency treatment of allergic reactions, including anaphylaxis. This novel formulation provides an alternative to traditional injectable epinephrine, potentially addressing barriers to rapid treatment. The approval is based on studies demonstrating bioequivalence to injectable epinephrine and similar cardiovascular effects in both adults and children weighing at least 30kg.

Key Points:

• Neffy is approved for adult and pediatric patients weighing 30kg or more
• The intranasal spray delivers a single 2mg dose of epinephrine into one nostril
• FDA approval was based on data from 4 studies involving 175 healthy adults
• Neffy showed bioequivalence to injectable epinephrine based on comparable blood concentrations
• Similar epinephrine concentrations were observed in children weighing ≥30kg compared to adults
• Cardiovascular effects (blood pressure and heart rate increases) were comparable between neffy and injectable epinephrine
• Common adverse reactions include throat irritation, intranasal paresthesia, headache, and nasal discomfort
• Patients with certain nasal conditions may experience altered absorption and should consider injectable alternatives
• A second dose can be administered after 5 minutes if needed, using a new spray in the same nostril
• Repeat dosing in the same nostril provides greater exposure than alternating nostrils
• Neffy has a 30-month shelf life and should be stored at room temperature
• It can withstand high temperatures up to 122°F for a few days
• Each carton contains two single-dose nasal sprays
• The product is expected to be available within 8 weeks of FDA approval

“The availability of epinephrine nasal spray may reduce barriers to rapid treatment of anaphylaxis.”
– Kelly Stone, MD, PhD, Associate Director of the Division of Pulmonology, Allergy and Critical Care in the FDA’s Center for Drug Evaluation and Research

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