Neffy (epinephrine nasal spray) has been approved by the FDA for the emergency treatment of Type I allergic reactions including life-threatening anaphylaxis. This provides an alternative route of administration of epinephrine to those (especially children) averse to injections and are faced with a life-threatening situation of anaphylaxis.
Epinephrine is the only life-saving treatment for anaphylaxis. It is available so far only as an injection usually administered through intramuscular (IM) or intravenous (IV) route. Neffy is the first epinephrine product for the treatment of anaphylaxis that is not administered by injection.
The approval of nasal spray is based on results from studies. The two routes viz. nasal spray and injection have shown comparable epinephrine blood concentrations following administration. They also showed similar increases in blood pressure and heart rate which are two critical effects of epinephrine in the treatment of anaphylaxis.
Neffy is a single dose nasal spray administered into one nostril. A second dose (using a new nasal spray to the same nostril) may be given if there is no improvement in symptoms or symptoms worsen. Patients may need to seek emergency medical assistance for close monitoring.
Contraindications are certain nasal conditions, like nasal polyps or a history of nasal surgery which may affect absorption, certain coexisting conditions and allergic reactions associated with sulfite. Patients with these conditions should consult with a health care professional to consider use of an injectable epinephrine product. Common side effects include throat irritation, tingling nose (intranasal paresthesia), headache, nasal discomfort, feeling jittery, tingling sensation (paresthesia), fatigue, tremor, runny nose (rhinorrhea), itchiness inside the nose (nasal pruritus), sneezing, abdominal pain, gum (gingival) pain, numbness in the mouth (hypoesthesia oral), nasal congestion, dizziness, nausea and vomiting.
Allergic reactions are abnormal reactions of a person’s immune system to a substance that normally does not cause symp
Anaphylaxis is considered a medical emergency. It is a severe, life-threatening allergic reaction that typically involves multiple parts of the body. Certain foods, medications and insect stings are common allergens that can induce anaphylaxis. Symptoms usually occur within minutes of exposure and include, but are not limited to, hives, swelling, itching, vomiting, difficulty breathing and loss of consciousness.
The FDA granted the approval of Neffy to ARS Pharmaceuticals.
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References:
- FDA Approves First Nasal Spray for Treatment of Anaphylaxis. Posted on 09 August 2024. Available at https://www.fda.gov/news-events/press-announcements/fda-approves-first-nasal-spray-treatment-anaphylaxis
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