New FDA Approval: NEFFY® (epinephrine)
The U.S Food and Drug Administration (FDA) recently approved approved Neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type I), including those that are life-threatening (anaphylaxis), in adult and pediatric patients who weigh at least 30 kilograms (about 66 pounds).
Read InpharmD's summary below:
| Drug Name |
NEFFY® (epinephrine) |
| Active Ingredient |
epinephrine |
| Date of Approval |
August 9th, 2024 |
| Manufacturer |
ARS Pharmaceuticals, Inc. |
| Approval Pathways and Indications |
Approval Pathway: NDA
Indication: NEFFY® is indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 30 kg or greater |
| Therapeutic Class |
Sympathomimetic Agent |
| Formulation |
Nasal spray: 2 mg/0.1 mL of epinephrine per spray |
| MoA |
NEFFY® acts on both alpha and beta-adrenergic receptors to counteract the effects of anaphylaxis. By targeting alpha-adrenergic receptors, it reduces vasodilation and increased vascular permeability, mitigating the risk of hypotension due to fluid loss. Its action on beta-adrenergic receptors helps relax bronchial smooth muscle, alleviating bronchospasm, wheezing, and dyspnea. |
| Dosing and Administration |
Recommended Dosage: one spray of NEFFY® (2 mg of epinephrine) administered into one nostril.
Administer NEFFY® by inserting the nozzle of the nasal spray fully into one nostril until your fingers touch the nose. Hold the nasal spray straight into the nose - do not angle the nasal spray to the inside septum or outer wall of the nose as some medication may be lost. Press the plunger firmly to activate. Avoid sniffing during and after administration. In absence of clinical improvement or if symptoms worsen after initial treatment, administer a second dose of NEFFY® in the same nostril with a new nasal spray starting 5 minutes after the first dose. |
| Administered by self or by HCP |
Administered by self |
| Place in Therapy |
NEFFY® is a needle-free, low-dose intranasal epinephrine spray for use at the first signs of an allergic reaction. It aims to improve patient and caregiver readiness by allowing quick and confident administration without the fear of needles.
While current epinephrine autoinjectors are effective, they have limitations, including needle fear, lack of portability, safety concerns, and complexity, which often cause delays in treatment during emergencies.
NEFFY®'s approval follows a year after the FDA initially withheld approval, requiring more trial data to assess the safety of repeated doses. |
| Expected Market Launch Date |
Within 8 weeks |
| New Molecular Entity (NME) or Existing Formulation |
Existing Formulation |
| Expected Cost |
$200 out of pocket |
| Product Discontinuation |
N/A |
| Clinical Trials |
In a study involving healthy adult subjects, NEFFY® was compared to intramuscular epinephrine injections (0.3 mg) using both needle-syringe and auto-injector products. After a single nasal dose of NEFFY® (2 mg), the median and mean increases in systolic blood pressure (SBP) and pulse rate (PR) were within the range of both epinephrine injection treatments during the first 10 minutes post-dose. Notably, NEFFY®"s responses were higher than those of both injection treatments through 60 minutes post-dose
Another study conducted on pediatric patients with type I allergy without anaphylaxis (ages 8 to 17, weighing 30 kg or greater) assessed the PK and PD of a single nasal dose of NEFFY® (2 mg). The median changes in SBP and PR over 60 minutes post-dose were numerically lower than those observed in healthy adults who received the same dose.
NEFFY® was well-tolerated in both adult and pediatric populations, with a safety profile consistent with the known effects of epinephrine. No unexpected adverse reactions were reported. The study demonstrated that NEFFY® achieved comparable systemic exposure to two intramuscular injections of epinephrine 0.3 mg, suggesting similar efficacy for severe allergic reactions. However, safety and effectiveness have not been established for patients weighing less than 30 kg. |
| Sources |
Drugs.com. FDA Approves Neffy Nasal Spray for Allergic Reactions. Available at: https://www.drugs.com/history/neffy.html. Accessed August 13, 2024.
ARS Pharmaceuticals. Neffy Prescribing Information. Available at: https://www.ars-pharma.com/wp-content/uploads/pdf/Prescribing_Information.pdf. Accessed August 13, 2024.
EMP. FDA Approves Neffy: An Epinephrine Nasal Spray for Anaphylaxis. Available at: https://www.empr.com/home/news/fda-approves-neffy-an-epinephrine-nasal-spray-for-anaphylaxis/. Accessed August 13, 2024.
CBS News. FDA approves Neffy, first nasal spray for severe allergic reactions: Here’s what to know. Available at: https://www.cbsnews.com/news/fda-approves-neffy-first-nasal-spray-severe-allergic-reactions-heres-what-to-know/. Accessed August 13, 2024. |
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