Before the FDA possibly approves the nation's first needle-free EpiPen product, the agency wants a San Diego-based drugmaker to conduct another study.
ARS Pharmaceuticals filed a new drug application for Neffy, an experimental epinephrine nasal spray that aims to treat severe allergic reactions, but the regulatory agency decided Sept. 19 to postpone its decision.
"The FDA requested completion of a pharmacokinetic/pharmacodynamic study assessing repeat doses of neffy compared to repeat doses of an epinephrine injection product under allergen-induced allergic rhinitis conditions to support approval," ARS Pharmaceuticals said in a news release.
ARS Pharmaceuticals President and CEO Richard Lowenthal said he was "very surprised" by the FDA's request, adding that FDA advisers did not voice concerns about allergen-induced acute rhinitis during a May meeting.
The company said it would conduct the study and plans to file again for approval in early 2024.