neffy From ARS Pharmaceuticals, Inc

The FDA has approved epinephrine nasal spray (neffy; ARS Pharmaceuticals, Inc) for the emergency treatment of type I allergic reactions, including anaphylaxis, in adults and pediatric patients with a weight of 30 kg or more.¹ Of the 40 million individuals in the US who are affected by type I severe allergic reactions, only 3.3 million have an active epinephrine auto-injector prescription, and of those, only half consistently carry it. Approximately 500,000 emergency department visits each year are due to type I allergic reactions, with almost 60% consisting of patients who did not receive epinephrine before their visit. Limitations to epinephrine auto-injector use include the complexity of the device, fear of the needle, lack of portability, lack of reliability, and needle-related safety concerns.²

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PHARMACOLOGY AND PHARMACOKINETICS

Epinephrine nasal spray is an α-adrenergic and β-adrenergic receptor agonist. Its α-adrenergic activity reduces vasodilation and increases vascular permeability, whereas its β-adrenergic activity results in bronchial smooth muscle relaxation. Epinephrine nasal spray displays a geometric mean plasma concentration-time profile within the range of an intramuscular dose of epinephrine 0.3 mg.¹

DOSAGE AND ADMINISTRATION

The recommended dosage of epinephrine nasal spray is 1 spray (2 mg of epinephrine) in 1 nostril. After 5 minutes, a second dose may be given in the same nostril with a new nasal spray if symptoms have not improved or have worsened. Patients should be counseled about when to obtain emergency medical assistance for close monitoring of an anaphylactic episode and when additional treatment is necessary. Because epinephrine nasal spray is supplied as a single-use medication and delivers the entire dose upon activation, patients should not prime or attempt to reuse the product. The medication is for nasal use only. Patients should be prescribed and have immediate access to 2 epinephrine nasal sprays at all times.¹

CLINICAL TRIALS

The approval of epinephrine nasal spray is based on data from 5 primary registration studies of a 2-mg intranasal dose of epinephrine, which were reinforced by pilot and supportive studies. The results from these studies found that epinephrine nasal spray demonstrated pharmacodynamic and pharmacokinetic data within the range of previously approved injectable epinephrine products. The studies consisted of healthy adults who received 1 or 2 doses, patients with type I allergies who self-administered or had a caregiver administer the medication, pediatric patients who weighed more than 30 kg, and individuals with allergic rhinitis.^1,2

CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS

There are no contraindications to treatment with epinephrine nasal spray.

Absorption of the medication may be affected by underlying anatomical or structural nasal conditions. Because epinephrine nasal spray may aggravate angina pectoris or produce ventricular arrhythmias, it should be used cautiously in patients with heart disease. Epinephrine can temporarily exacerbate diabetes, hyperthyroidism, Parkinson disease, and renal impairment. The medication should also be used cautiously in elderly patients and during pregnancy. Epinephrine nasal spray contains sodium metabisulfite, which should not be a deterrent to its use.

Epinephrine nasal spray may alter nasal mucosa for up to 2 weeks after administration and increase systemic absorption of nasal products, including epinephrine. Patients should be observed for cardiac arrhythmias when it is used concomitantly with antiarrhythmic agents, cardiac glycosides, or diuretics. The effects of epinephrine may be potentiated when it is used concomitantly with catechol-O-methyltransferase inhibitors, certain antihistamines, levothyroxine sodium, monoamine oxidase inhibitors, and tricyclic antidepressants. Concurrent use of β-adrenergic blocking drugs can antagonize the cardio-stimulating and broncho-dilating effects of epinephrine, whereas concurrent use of α-adrenergic blocking drugs can antagonize the vasoconstricting and hypertensive effects of epinephrine. The use of ergot alkaloids may reverse
the pressor effects of epinephrine.
The most common adverse reactions are abdominal pain, dizziness, fatigue, feeling jittery, gingival pain, headache, oral hypoesthesia, intranasal paresthesia, nasal congestion, nasal discomfort, nasal pruritus, nausea, paresthesia, rhinorrhea, sneezing, throat irritation, tremor, and vomiting.¹

REFERENCES

1. Neffy. Prescribing information. ARS Pharmaceuticals Operations Inc; 2024. Accessed November 25, 2024. https://www.ars-pharma.com/wp-content/uploads/pdf/Prescribing_Information.pdf

2. ARS Pharmaceuticals receives FDA approval of neffy (epinephrine nasal spray), the first and only needle-free treatment for type I allergic reactions, including anaphylaxis. News release. ARS Pharmaceuticals Inc. August 9, 2024. Accessed November 25, 2024. https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-receives-fda-approval-neffyr-epinephrine