FDA says it needs more research before deciding to approve nasal spray to treat dangerous allergies
The U.S. Food and Drug Administration declined to approve a nasal spray to treat severe allergic reactions, calling for more research on what would have been the first alternative to injections using devices such as an EpiPen
Federal regulators declined to approve a nasal spray to treat severe allergic reactions late Tuesday, calling for more research on what would have been the first alternative to injections using devices such as an EpiPen.
The U.S. Food and Drug Administration told ARS Pharmaceuticals Inc., of San Diego, that the company needs to conduct another study on repeat doses of epinephrine, a drug that halts potentially life-threating reactions, called anaphylaxis, using the company's nasal spray device compared with injections.
The move comes four months after an FDA advisory committee recommended approval of the device, dubbed neffy. The FDA is not required to follow the committee's recommendations, though it usually does.
Richard Lowenthal, president and chief executive of ARS, said in a statement that the company would appeal the FDA's decision and resubmit an application in early 2024.
