The first epinephrine nasal spray for emergency allergic reactions receives FDA approval | CNN

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The US Food and Drug Administration approved the first epinephrine nasal spray for severe allergic reactions called anaphylaxis, a needle-free alternative to EpiPens and similar drugs.

The drug, called Neffy, is cleared for adults and children who weigh more than 66 pounds, the agency said Friday in a news release. It is given as a single dose sprayed into one nostril. A second dose can be given if needed, similar to injectable epinephrine, the agency said.

Neffy uses the same nebulizer as Narcan, the naloxone nasal spray for opioid overdoses, according to a spokesman for its maker, ARS Pharmaceuticals.

“Anaphylaxis is life-threatening and some people, especially children, may delay or avoid treatment due to fear of injections,” said Dr. Kelly Stone, associate director of pulmonology, allergy and critical care in the FDA’s Center for Drug Evaluation and Research. “Availability of epinephrine nasal spray may reduce barriers to rapid treatment of anaphylaxis.”

The approval was based on studies of 175 healthy adults that measured blood levels of epinephrine, which showed comparable levels for Neffy and injected epinephrine, as well as similar increases in blood pressure and heart rate. A study of children weighing more than 66 pounds found comparable levels of adrenaline to adults.

The drug had been expected to be approved last year, but it was delayed as the FDA sought more information about repeated dosing. The FDA said Friday that patients may need to see an emergency physician for close monitoring after having an anaphylaxis and if further treatment is needed. It is also recommended that patients receiving epinephrine by injection seek immediate emergency care.

The FDA noted that people with nasal conditions such as nasal polyps or who have undergone rhinoplasty may not be able to adequately absorb Neffy and should talk to a healthcare provider about whether epinephrine by injection is better for them.

The agency said Neffy’s most common side effects are throat irritation, tingling, headache, nasal discomfort and irritability, among others.

Anaphylaxis is most often caused by a reaction to drugs, foods or insect stings, according to the American Academy of Allergy, Asthma and Immunology. Symptoms, which usually begin within five to 30 minutes of contact with the allergen, include hives, swelling of the throat and other areas, wheezing and passing out.

“Anyone who has experienced or witnessed an anaphylaxis knows that deciding when to inject themselves or a child with epinephrine can be very stressful and often delayed,” said Dr. press release from ARS Pharmaceuticals. “We know earlier management is better and for many people the needle is a barrier that causes dangerous hesitation.” Therefore, the field has long pursued an effective treatment method that does not require injection.”

ARS Pharmaceuticals did not disclose Neffy’s list price — how much it costs before insurance or other discounts — in its press release Friday. It said that for patients with commercial insurance that covers the drug, the out-of-pocket price would be no more than $25 for two disposable devices, through a co-pay plan. For certain patients without insurance or who face high out-of-pocket costs, the company said the price will be $199 for two doses of Neffy. For other patients who cannot afford the drug, the company said it would provide Neffy for free.

The drug is expected to be available in the United States within eight weeks, ARS said. The company also noted that it plans to apply for FDA approval for Neffy for children weighing between 15 and 30 kg (33 to 66 pounds) by the end of the third quarter of this year, or by October.

CNN’s Jen Christensen contributed to this report.