In a surprise move, the Food and Drug Administration has rejected the application for an epinephrine nasal spray that offered a needle-free alternative to the EpiPen.
ARS Pharmaceuticals announced the FDA’s denial, saying that the federal agency issued “a complete response” asking for more studies on the Neffy 2-milligram nasal spray, The Washington Post reported.
Neffy was developed to reverse anaphylaxis, the most severe type of allergic reaction that could be deadly without treatment.
Epinephrine is the traditional treatment for reversing the reaction, but for people with needle phobias, that can be an issue, NBC News reported.
“There are no alternatives right now,” Dr. Zachary Rubin, an Illinois allergist, told NBC News. “You basically have epinephrine autoinjector devices, needle options, and people have been clamoring for years to get a needle-free option.”
But the FDA’s advisory board, which voted to approve Neffy in May, said there was not enough clinical data since it was not tested in people who were having an anaphylaxis attack. It is rare that the FDA does not follow the recommendations of its advisory board, the Post reported.
Dr. Maryann Amirshahi said that was why she voted against approval of the treatment.
“I listened to the parents in the hearing and I heard them talk about how traumatic it was to give their children a shot,” Amirshahi told NBC News via email. “But to me, as a parent, panel member, pharmacologist, and ER doc who has seen her fair share of anaphylaxis, the scary thing was not the shot, but a drug failing in treating a life-threatening condition.”
Viatris, the makers of the EpiPen, also asked the FDA in June to require that ARS, the developer of Neffy, conduct more trials that are closer to real-world conditions, Reuters reported. ARS compiled its data from people who were having a rhinitis attack, with the spray having a similar response to an injectable medication.
The rejection does not mean that there is no hope for a non-needle treatment. The company plans on resubmitting an application for approval next year. The potential approval could happen in the second half of 2024, Reuters reported.
