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WASHINGTON - On Friday, the U.S. Food and Drug Administration approved a nasal spray for the emergency treatment of allergic reactions – the first needle-free alternative to shots like EpiPen.
The nasal spray, marked as neffy, is intended as an emergency treatment for adult and pediatric patients who weigh at least 66 pounds. The device could upend treatment for the 33 million to 45 million Americans with severe allergies to food and other triggers.
The FDA said it approved the spray from drugmaker ARS Pharmaceuticals Inc.
"Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections," said Kelly Stone, the associate director of the division of pulmonology, allergy and critical care in the FDA’s Center for Drug Evaluation and Research. "The availability of epinephrine nasal spray may reduce barriers to rapid treatment of anaphylaxis. As a result, neffy provides an important treatment option and addresses an unmet need."
What is Neffy?
Neffy is a single-dose nasal spray administered into one nostril.
As with epinephrine injection products, a second dose may be given if there is no improvement in symptoms or symptoms worsen, according to the FDA.
Product photo of neffy (Credit: ARS Pharma)
Neffy comes with a warning that certain nasal conditions, such as nasal polyps or a history of nasal surgery, may affect absorption of neffy, and patients with these conditions should consult with a health care professional to consider use of an injectable epinephrine product.
Neffy also comes with warnings and precautions about use of epinephrine by people with certain coexisting conditions and allergic reactions associated with sulfite.
The most common side effects of neffy include throat irritation, tingling nose, headache, nasal discomfort, feeling jittery, tingling sensation, fatigue, tremor, runny nose, itchiness inside the nose, sneezing, abdominal pain, gum pain, numbness in the mouth, nasal congestion, dizziness, nausea and vomiting.
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Neffy is designed to be easy to carry and easy to use, especially for children, said Richard Lowenthal, president and chief executive of San Diego-based ARS.
"We don’t want fear. There’s no needle, there’s no pain with this product," he said. "It’s basically like spraying saline into your nose."
Neffy will come in packs of two and is expected to cost about the same as a two-pack of auto-injectors, around $300 to $700.
Lowenthal said he hoped insurance companies would cover the cost to patients for a low co-pay amount.
What is anaphylaxis?
Allergic reactions happen when a person’s immune system reacts abnormally to a substance that normally does not cause symptoms.
Anaphylaxis is a severe, life-threatening allergic reaction that typically involves multiple parts of the body and is considered a medical emergency.
Common allergens that can induce anaphylaxis include certain foods, medications and insect stings.
Symptoms usually occur within minutes of exposure and include, but are not limited to, hives, swelling, itching, vomiting, difficulty breathing and loss of consciousness.
Anaphylaxis sends more than 30,000 people to emergency rooms and results in more than 2,000 hospitalizations and more than 230 deaths in the U.S. each year.
Epinephrine is the only life-saving treatment for anaphylaxis and has previously only been available for patients as an injection.
Neffy’s approval based on previous studies
Clinical trials of people experiencing potentially deadly reactions are difficult for ethical and pragmatic reasons. Instead, researchers compared the effect of the nasal spray on biological markers to existing epinephrine treatments.
Neffy’s approval was based on four studies in 175 healthy adults, without anaphylaxis, that measured the epinephrine concentrations in the blood following administration of neffy or approved epinephrine injection products.
Results from these studies showed comparable epinephrine blood concentrations between neffy and approved epinephrine injection products.
Neffy also demonstrated similar increases in blood pressure and heart rate as epinephrine injection products, two critical effects of epinephrine in the treatment of anaphylaxis.
Another study of neffy in children weighing more than 66 pounds showed that epinephrine concentrations in children were similar to adults who received neffy.
Other needle-free epinephrine devices are being developed to treat allergic reactions. In the pipeline are nasal sprays from Bryn Pharma, of North Carolina, and Nausus Pharma, of Israel; a needle-free auto-injector from Crossject of France; and an epinephrine film that is administered under the tongue from Aquestive Therapeutics, of New Jersey.
This story was reported from Los Angeles.