The Food and Drug Administration on Friday approved a nasal spray to treat severe allergic reactions, expanding options beyond needle-based treatments like the EpiPen.
The nasal spray, called Neffy, from drugmaker ARS Pharmaceuticals, is approved for treating allergic reactions, including life-threatening anaphylaxis, in adults and children weighing at least 66 pounds.
The approval comes nearly a year after the FDA’s previous decision not to approve Neffypending more trial data. According to the ARS, FDA regulators decided at the time that more data were needed to assess the safety of repeated doses of the nasal spray before it could be approved.
“Neffy is epinephrine, the same medication as the EpiPen, but it’s administered through the nose instead of by injection,” Dr. Celine Gounder, a CBS News medical contributor and senior public health editor at KFF Health News, told “CBS Mornings” Monday. “Neffy appears 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, a lot of times, and so this is a good alternative to make sure that parents aren’t afraid to administer this life-saving treatment.”
As with the EpiPen, after Neffy is administered, patients should go to the emergency room for monitoring.
“It’s the same thing because it’s not necessarily a definitive treatment for the allergy. It should be considered life-saving, but additional treatment may be needed in the emergency room,” Gounder said.
Neffy Side Effects
The spray may cause some side effects, including:
- Nasal irritation
- Throat irritation
- Headaches
- Nervousness
“A lot of this is due to the epinephrine itself,” Gounder said.
Is Neffy available now?
Gounder says the drug should be available about eight weeks after FDA approval.
In terms of cost, the fee is around $200 to pay out of pocket.
“For people who have commercial insurance, the cost will be limited to about $25,” Gounder said. “And for people who are underinsured or uninsured, the cost will be free for at least some of them, which is very important because 40 percent of children in the United States have insurance.” Medical aid or public insurance.”
