SER120 is the first FDA-approved pharmacotherapy for nocturia. SER120 efficacy/safety was evaluated in 2 randomized, double-blind, placebo-controlled studies (DB3 and DB4).
Patients aged ≥50 years with ≥ 2.
16 nocturic voids/night during a 2-week screening period (N=1,333, intent-to-treat) were randomized equally to SER120 (intranasal spray) 1.66 mcg, 0.83 mcg, or placebo for a 12-week treatment. Co-primary endpoints: mean change from baseline in nocturic episodes/night and percentage of patients with ≥50% reduction in mean nocturic episodes/night. Secondary endpoints: validated QoL questionnaire, Impact of Nighttime Urination [INTU]) (DB4), time to first nocturic void, and percentage of nights with ≤1 nocturic voids.
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. SER120 1.66 mcg demonstrated significant improvements in INTU score (p = 0.0255). Hyponatremia (serum sodium ≤125 mmol/L regardless of symptoms or <130 mmol/L with symptoms) was 1.1%, 0% and 0.2% in the 1.66 mcg, 0.83 mcg and placebo groups, respectively. Other adverse events were similar across treatment groups.
SER120 demonstrated significant improvements over placebo for co-primary and secondary efficacy endpoints that corresponded with QoL improvements. SER120 at both doses had an acceptable safety profile.
clinicaltrials.gov Identifiers: NCT01357356; NCT01900704.
The Journal of urology. 2018 Apr 11 [Epub ahead of print]
Jed Kaminetsky, Seymour Fein, Roger Dmochowski, Scott MacDiarmid, Steven Abrams, Maria Cheng, Alan Wein
NYU Medical Center, New York, New York. Electronic address: ., Serenity Pharmaceuticals LLC, Milford, Pennsylvania., Vanderbilt University, Nashville, Tennessee., Alliance Urology Specialists, Greensboro, North Carolina., Allergan plc, Irvine, California., University of Pennsylvania, Philadelphia, Pennsylvania.
Go Beyond the Abstract and Read a Commentary by Seymour Fein, MD