FDA Committee Recommends Epinephrine Nasal Spray for Severe Allergic Reactions
The Food and Drug Administration’s Pulmonary-Allergy Drugs Advisory Committee voted on May 11 to recommend an epinephrine nasal spray product for the treatment of severe allergic reactions, including anaphylaxis.
The 22-member advisory committee voted 16–6 to recommend approval of the 2 milligram epinephrine saline-based spray, marketed as Neffy, for adults.
It voted 17–5 to recommend the spray for children who weigh more than 30 kilograms—about 66 pounds—concluding that available data support “a favorable benefit-risk assessment” of the spray.
If approved, Neffy, developed by biotechnology company ARS Pharmaceuticals, will become the first needle-free epinephrine product for the treatment of severe allergic reactions.
In a press release, Richard Lowenthal, president and CEO of ARS Pharmaceuticals, said that data stemming from clinical trials conducted among more than 600 individuals show that Neffy’s absorption-enhancing nasal spray technology is “comparable to injectable products in delivering potentially lifesaving epinephrine” but has the added advantage of being small, needle-free, and conveniently sized….