FDA approves first nasal spray for severe allergic reactions. Here's what to know.
The Food and Drug Administration approved a nasal spray intended to treat severe allergic reactions on Friday, expanding options beyond needle-based treatments like the EpiPen.
The nasal spray, called Neffy, from drugmaker ARS Pharmaceuticals, is approved for the treatment of allergic reactions, including life-threatening anaphylaxis, in adults and children who weigh at least 66 pounds.
The approval comes nearly a year after the FDA previously decided not to approve Neffy, pending more trial data. According to ARS, the FDA regulators decided at the time that more data was needed to evaluate the safety of repeated doses of the nasal spray before it could be approved.
"Neffy is epinephrine, the same medication that is in the EpiPen, but it's delivered through the nose rather than through an injection," Dr. Céline Gounder, CBS News medical contributor and editor-at-large for public health at KFF Health News, told "CBS Mornings" Monday. "Neffy seems to be as effective as the EpiPen, which is great news. I think for a lot of parents — parents are just as afraid of needles as kids are, oftentimes, and so this gives a nice alternative to make sure that parents are not afraid to give this life-saving treatment."
Similar to EpiPens, after administering Neffy, patients should go to the ER to be monitored.
"It is the same because that is not necessarily definitive treatment for the allergy. It should be seen as a rescue, but additional treatment may be needed in the ER," Gounder said.
Neffy side effects
There are some potential side effects to the spray, including:
- Nasal irritation
- Throat irritation
- Headaches
- Jitteriness
"A lot of that has to do with the epinephrine itself," Gounder said.
Is Neffy available now?
Gounder says the drug is meant to be available about eight weeks from the FDA approval.
In terms of cost, the fee is about $200 out of pocket.
"For people who are on commercial insurance, the cost is going to be limited to about $25," Gounder said. "And then for people who are underinsured or uninsured, it's going to be made no cost for at least some of them, which is really important, because 40% of kids in the United States are on Medicaid or public insurance."