"There is a total unmet need": Allergist, parent respond after EpiPen alternate not approved by FDA
(CBS DETROIT) - "Needles aren't something that's necessarily pleasant," says 15-year-old Evan Rutter, who struggles with a serious nut allergy.
An emergency allergic reaction medication called Neffy was denied approval by the U.S. Food and Drug Administration Wednesday morning. The nasal spray alternative to an EpiPen has parents wondering when we could see the spray, or something similar to it, become available to families that have members with severe allergies.
"Nose spray would be a lot easier than having to pull this off, put it in your leg, and having to like teach everyone how to use it. But everyone knows how to use nose spray, right?" said Rutter while demonstrating what would happen if he had a serious allergic reaction.
Neffy comes from drugmaker ARS Pharmaceuticals. They say FDA regulators needed more data to evaluate the safety of repeated doses of the nasal spray.
"Anaphylaxis can kill you. So it might be that the company may have to do these controlled anaphylactic reactions but maybe in like an emergency room setting where if the Neffy didn't work, you have an alternative," says allergist and physician Kathleen Dass.
Dass echoes the Rutter family and said a spray could be a game changer when it comes to anaphylaxis treatment.
"I think there is a total unmet need. I've had patients tell me that they've delayed using their epinephrine auto-injector because they were worried maybe it wasn't serious," says Dass. "If you're having a serious allergic reaction, there's always the potential that it could kill you, so you're never overreacting," Dass said.