Neffy FDA Approval Status
Last updated by Judith Stewart, BPharm on Sep 20, 2023.
FDA Approved: No
Brand name: neffy
Generic name: epinephrine
Dosage form: Nasal Spray
Company: ARS Pharmaceuticals, Inc.
Treatment for: Anaphylaxis
neffy® (epinephrine) is an intranasal epinephrine formulation in development for the treatment of allergic reactions (Type 1), including anaphylaxis, for adults and children ≥30 kg.
- 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.
- 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 intended for use at the first signs of an allergic response. neffy® may 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.
- On September 19, 2023, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for neffy in the treatment of Allergic Reactions (Type I), including anaphylaxis for adults and children ≥30 kg. In the letter, the FDA requested the completion of a pharmacokinetic/pharmacodynamic study assessing repeat doses of neffy compared to repeat doses of an epinephrine injection product under allergen-induced allergic rhinitis conditions to support approval. In May 2023, the FDA Advisory Committee (PADAC) had recommended to approve neffy without the need for additional studies to demonstrate its efficacy or safety. ARS Pharma plans to submit a Formal Dispute Resolution Request (FDRR) to appeal the issuance of the CRL.
Development timeline for neffy
Further information
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