Kaminetsky J, et al. - Experts ascertained the efficacy/safety of SER120 in nocturia patients in 2 randomized, double-blind, placebo-controlled studies (DB3 and DB4). Significant improvements were demonstrated with SER120 over placebo for co-primary and secondary efficacy endpoints that corresponded with Quality of Life (QoL) improvements. At both doses, SER120 had an acceptable safety profile.

Methods

• Researchers randomized the patients aged ≥50 years with ≥ 2.16 nocturic voids/night during a 2-week screening period (N=1,333, intent-to-treat) equally to SER120 (intranasal spray) 1.66 mcg, 0.83 mcg, or placebo for a 12-week treatment.
• The co-primary endpoints included mean change from baseline in nocturic episodes/night and percentage of patients with ≥50% reduction in mean nocturic episodes/night.
• Validated QoL questionnaire, Impact of Nighttime Urination [INTU]) (DB4), time to first nocturic void, and percentage of nights with ≤1 nocturic voids were the secondary endpoints.

Results

• As per the data, both doses of SER120 showed statistical significance vs placebo for both co-primary endpoints (mean nocturic episodes/night, -1.4 with 0.83 mcg and -1.5 with 1.66 mcg vs -1.2 with placebo [p < 0.0001 for both]; percentage of patients ≥50% reduction in mean nocturic episodes/night, 37.9% with 0.83 mcg and 48.7% with 1.66 mcg vs 30.3% with placebo [p = 0.0227 and p < 0.0001, respectively]) and all secondary endpoints in the pooled analyses.
• In INTU score (p = 0.0255), SER120 1.66 mcg demonstrated significant improvements.
• Findings suggested the hyponatremia (serum sodium ≤125 mmol/L regardless of symptoms or <130 mmol/L with symptoms) to be 1.1%, 0% and 0.2% in the 1.66 mcg, 0.83 mcg and placebo groups, respectively.
• Across treatment groups, other adverse events were similar.