European Medicines Agency accepts submission of Marketing Authorization Application for NeffyTM (ARS-1; epinephrine nasal spray) for emergency treatment of severe allergic reactions, including anaphylaxis
Submission includes data from multiple clinical studies showing that 1 mg of Neffy achieves adrenaline exposures that are similar to a 0.3 mg adrenaline IM injection or EpiPen, with rapid absorption (time to peak plasma levels) and clinical response based on surrogate endpoints.
Source:
Biospace Inc.