FDA advisers clear hurdle for epinephrine nasal spray

A Food and Drug Administration (FDA) advisory panel has approved an epinephrine nasal spray, clearing a hurdle for the product designed to help those with severe, potentially life-threatening allergic reactions. 

The panel, the Pulmonary-Allergy Drugs Advisory Committee, voted on Thursday to support the approval of Neffy, a spray that would give users a 2-milligram dose to treat allergic reactions, including anaphylaxis, as an alternative to an injection with a needle. 

The committee recommended the spray, which is produced by ARS Pharmaceuticals Inc., for adults in a 16-6 vote and for minors weighing at least 30 kilograms in a 17-5 vote.

The allergic reactions Neffy can treat result from food, insect bites or stings, drugs, serum, diagnostic testing substances and other allergens, according to the briefing document for the drug for the committee. It can also address idiopathic anaphylaxis, which does not have a clear cause, and exercise-induced anaphylaxis. 

With the committee’s approval, the company’s application now goes to the FDA for approval. The company said in a release earlier this week that it expects the FDA to take action in mid-2023. 

CBS reported the company sought to skip large clinical trials in favor of comparing the spray to other products used to treat allergic reactions through injection, and the FDA asked the committee if more studies should be required.

But the agency also noted challenges that studies for those with life-threatening allergic reactions face, given that they already have available treatments.