Neffy FDA Approval History
Last updated by Judith Stewart, BPharm on March 6, 2025.
FDA Approved: Yes (First approved August 9, 2024)
Brand name: Neffy
Generic name: epinephrine
Dosage form: Nasal Spray
Company: ARS Pharmaceuticals, Inc.
Treatment for: Anaphylaxis
Neffy® (epinephrine) is an intranasal epinephrine formulation for the emergency treatment of allergic reactions.
- neffy® is an alpha and beta-adrenergic receptor agonist indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients 4 years of age and older who weigh 15 kg or greater.
- Type I severe allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only FDA-approved medication for these reactions.
- Epinephrine works in the treatment of allergic reactions by acting on alpha-adrenergic receptors to lessen vasodilation and on beta-adrenergic receptors to relax bronchial smooth muscle.
- The epinephrine autoinjectors that are currently available have been shown to be highly effective, however they come with limitations, and many patients and caregivers delay or do not administer the treatment in an emergency situation. The limitations include fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices.
- neffy® is a needle-free, low-dose intranasal epinephrine nasal spray for use at the first signs of an allergic response. neffy® is intended to provide improved patient and caregiver preparedness and response with the ability to give epinephrine quickly, confidently, and without hesitation that is caused by fear of needles.
- neffy® is available in two strengths:
- 1 mg/0.1 mL of epinephrine per spray for children 15 kg to less than 30 kg
- 2 mg/0.1 mL of epinephrine per spray for adults and children ≥30 kg. - neffy® is administered as one spray into one nostril. In the absence of clinical improvement or if symptoms worsen after initial treatment, a second dose may be administered in the same nostril with a new nasal spray starting 5 minutes after the first dose.
- Warnings and precautions associated with neffy® include using with caution in patients with heart disease and aggravation of certain coexisting conditions.
- Common adverse reactions:
- in adults (incidence > 2%) include nasal discomfort, headache, rhinorrhea, dizziness, nausea, vomiting, and throat irritation.
- in pediatric patients 4 years of age and older who weigh 15 kg or greater (incidence >10%) include nasal discomfort, nasal congestion, paresthesia, rhinorrhea, sneezing, upper respiratory tract congestion, epistaxis, rhinalgia, nasal dryness, dry throat, fatigue, and feeling jittery.
Development timeline for Neffy
Further information
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