Allergan Nasal Spray For Frequent Nighttime Urination Faces Review Hurdles

Advisory committee will weigh in on desmopressin as FDA questions broad indication and says clinical meaningfulness of treatment effects for Serenity Pharmaceuticals/Allergan’s product vs. placebo are unclear.

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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