US EditionFDA rejects first needle-free alternative to EpiPens, calling for additional research
- The FDA has declined to approve the first needle-free epinephrine treatment for severe allergic reactions, requesting more testing from the developer, ARS Pharmaceuticals.
- ARS Pharmaceuticals plans to resubmit their application in the first half of next year, with FDA action likely in the second half, expressing disappointment for the delay in making the treatment available.
- The FDA has asked ARS Pharmaceuticals to conduct a repeat-dose study on the nasal spray before potential approval, even though an agreement was made for the study to be conducted after the spray hit the market.
42 Articles
42 Articles
FDA declines to approve neffy, a needle-free EpiPen alternative
This story has been updated to clarify the drug application's status. CHICAGO (NewsNation) — The Food and Drug Administration did not approve a new nasal spray for allergic reactions, requesting further studies and review of the proposed treatment before a final decision. ARS Pharmaceuticals, Inc.'s experimental drug, neffy, would work as a needle-free alternative to epinephrine autoinjectors, including EpiPens. Neffy would be used as a nasal sp…
FDA declines to approve needle-free epinephrine, asks drugmaker for more data
(CNN) — The U.S. Food and Drug Administration on Tuesday did not approve a needle-free epinephrine for the treatment of severe allergic reactions, a move that drugmaker ARS Pharmaceuticals called surprising. Instead, the agency requested more information about the nasal spray, including a study of repeat doses, ARS said in a news release. In May, an independent advisory committee to the FDA recommended the agency approve the drug, called Neffy. …
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