Efficacy and Safety of SER120 Nasal Spray in Patients with Nocturia: Pooled Analysis of Two Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trials

The study evaluated the efficacy and safety of SER120 desmopressin intranasal spray for treating nocturia in 1,333 patients aged 50 or older across two randomized, double-blind, placebo-controlled Phase 3 trials. Patients were treated with either 1.66 mcg or 0.83 mcg of SER120 or a placebo for 12 weeks. Results showed that both doses of SER120 significantly reduced nocturic episodes per night compared to placebo, with the 1.66 mcg dose also improving quality of life scores. The incidence of hyponatremia was low, and other adverse events were similar across all groups, indicating an acceptable safety profile for SER120.