FDA Panel Recommends Approval of First Nasal Spray to Combat Severe Allergic Reactions

FDA Panel Recommends Approval of First Nasal Spray to Combat Severe Allergic Reactions

Outside advisers for the U.S. Food and Drug Administration voted Thursday to recommend approval of Neffy, the first epinephrine nasal spray for severe allergic reactions.

Although most of the Pulmonary-Allergy Drugs Advisory Committee members supported the spray for adults (16:6) and children (17:5), key questions linger about whether more data are needed from its maker, ARS Pharmaceuticals, CBS News reported.

But Richard Lowenthal, cofounder, president, and CEO at ARS, said in a company statement following the vote, “We believe our clinical data from more than 600 individuals demonstrate Neffy’s absorption-enhancing nasal spray technology is comparable to injectable products in delivering potentially lifesaving epinephrine, but with unique advantages of being small, needle-free, and conveniently sized.”

Neffy delivers a 2-mg dose of epinephrine. Instead of large clinical trials, the drug company compared its product to already approved injectable epinephrine products, such as the EpiPen. It showed the results for Neffy were neither substantially higher or lower than injectable epinephrine.