FDA advisers clear hurdle for epinephrine nasal spray


FDA advisers clear hurdle for epinephrine nasal spray | The Hill









FDA advisers clear hurdle for epinephrine nasal spray  at george magazine

FDA Building 21 stands behind the sign at the campus’s main entrance and houses the Center for Drug Evaluation and Research. The FDA campus is located at 10903 New Hampshire Ave., Silver Spring, MD 20993. (FDA/Flickr)

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 17-5 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 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. 

The company that produces Neffy, ARS Pharmaceuticals Inc., is requesting approval for anyone weighing at least 60 pounds to be able to use the spray. 

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.

Tags

allergic reactions


epinephrine


fda


Food and Drug Administration


nasal spray


Neffy


Pulmonary-Allergy Drugs Advisory Committee


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