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Revolutionary new nasal spray for anaphylaxis approved by FDA is a ‘big deal’, says allergist
The FDA has just approved a new nasal spray for the treatment of anaphylaxis, and an allergist says this is a really “big deal” for so many people.
This is the first ‘needle-free’ treatment available for people with severe allergies, so there is finally an alternative to EpiPens that doesn’t require any injections.
FDA approves nasal spray for anaphylaxis
“Today, the U.S. Food and Drug Administration approved neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type I), including those that are life-threatening (anaphylaxis),” the US Food and Drug Administration (FDA)�said.
The nasal spray has currently been approved for use in adult patients who weigh at least 30 kilograms (66 pounds) only. However, this could be expanded to children in the future after more research is completed.
Anaphylaxis is a life-threatening allergic�reaction that usually starts within minutes of coming into contact with something you are allergic to, like a food, medicine or insect sting, the NHS explains. It causes swelling of the throat and difficulty breathing.
Neffy is a single-dose nasal spray that is administered into one nostril, making anaphylaxis treatment quicker than ever. A second dose may then be given if there is no improvement in symptoms or if symptoms worsen.
It contains epinephrine, also known as adrenaline. This is the same medication used inside EpiPens to treat allergic reactions.
The nasal spray has been approved based on four studies in 175 healthy adults, without anaphylaxis, that measured the concentrations of epinephrine in the blood after administering neffy compared to other epinephrine injection products.
Results showed comparable epinephrine blood concentrations between both and neffy demonstrated similar increases in blood pressure and heart rate, which are vital in the treatment of anaphylaxis.
Allergist says nasal spray is a ‘big deal’
Dr. Zachary Rubin, a medical doctor who�specializes in�allergy�and immunology has called the innovation a “big deal” and a “very exciting day for many people”.
“The FDA has finally approved the first needle-free alternative to EpiPens or other epinephrine auto-injector devices,” he continued.
Before this, the only treatment for allergic reactions was EpiPens, small needles called auto-injectors which are administered by you or your caregiver. These�devices are designed to make the injection experience more manageable, but injecting yourself is still a very difficult process for many.
Neffy provides an alternative that doesn’t require any needles but still delivers the immediate anaphylaxis treatment that is vital during a severe allergic reaction.
The nasal spray will revolutionize allergy treatment and people are really excited about it, with one person commenting “Finally” and another adding: “This makes me so happy.”
Side effects, cost and when neffy goes on sale
Certain nasal conditions, such as nasal polyps or a history of nasal surgery, may affect absorption of neffy, so pome people may not be able to use it.
The most common side effects include throat irritation, tingling nose, headache, nasal discomfort, feeling jittery, tingling, fatigue, tremor, runny nose, itchiness inside the nose, sneezing, abdominal pain, gum pain, numbness in the mouth, nasal congestion, dizziness, nausea and vomiting.
Neffy is expected to go on sale across the United States�within eight weeks of FDA�approval, so sometime before October.
ARS Pharma has revealed that most commercially insured patients will pay�$25�for each prescription of two single-use�neffy�devices. They will also be will be selling it for a cash price of�$199�for two doses of�neffy�via digital pharmacy BlinkRx.
Dr. Zachary Rubin (MD) is a double board-certified pediatrician specializing in allergy and immunology at Oak Brook Allergists in Illinois. He gained his medical degree from Case Western Reserve University School of Medicine.
