FDA Requests More Data for Needle-Free Epinephrine Alternative
The US Food and Drug Administration (FDA) has declined to approve a needle-free epinephrine nasal spray for the treatment of severe allergic reactions. The FDA requested more data from drugmaker ARS Pharmaceuticals, including a study on repeat doses. The decision comes despite a positive recommendation from an independent advisory committee. If approved, the nasal spray, called Neffy, would be the first needle-free epinephrine treatment. The FDA's decision has disappointed patient advocacy groups who believe a nasal spray option would provide more options and be easier to use for people with severe allergies. ARS Pharmaceuticals plans to resubmit the necessary data in the first half of 2024.