FDA has raised several questions about Serenity Pharmaceuticals LLC/Allergan PLC’s desmopressin nasal spray for treatment of nocturia, including about the study design, the clinical meaningfulness of efficacy data, and the proposed broad patient population, which suggest the sponsor may have a difficult time before FDA’s advisory panel.
FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee is to consider the new drug application for Serenity’s SER120 (desmopressin nasal spray) at its Oct. 19 meeting
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