E-Posters-10231

10231_Van Drie
Pdf Summary
A study presented at the American Urogynecologic Society's Annual Scientific Meeting evaluated the effectiveness and safety of SER120, a nasal spray formulation of desmopressin, in treating patients with nocturia due to nocturnal polyuria (NP) and concomitant overactive bladder (OAB). The study included 207 patients from two phase 3 clinical trials. The patients underwent a 12-week treatment period with SER120 or placebo, and their nocturic episodes, time from bedtime to first nocturic void, number of nights with ≤1 episode, and health-related quality of life (HRQoL) were assessed. <br /><br />Results showed that patients treated with SER120 (both 1.66 mcg and 0.83 mcg doses) experienced a significant reduction in nocturic episodes compared to those receiving placebo. The reduction in nocturic episodes was more than double for the 1.66 mcg dose and almost double for the 0.83 mcg dose. Furthermore, a higher percentage of patients in the SER120 group achieved a ≥50% reduction in nocturic episodes compared to the placebo group. <br /><br />Secondary endpoints, including time from bedtime to first nocturic void and the number of nights with ≤1 episode, also showed significant improvements in the SER120 group. Furthermore, patients in the SER120 group reported improved HRQoL compared to those in the placebo group. <br /><br />The study also assessed the safety and tolerability of SER120 and found it to be well-tolerated, with only two patients in the 1.66 mcg dose group experiencing low serum sodium levels. The most commonly reported adverse events included nasal discomfort, depression, rhinorrhea, headache, nasopharyngitis, sneezing, decreased blood sodium, and constipation. <br /><br />Overall, the study concluded that SER120 is an effective and safe treatment for patients with nocturia due to NP and concomitant OAB. It significantly reduced nocturic episodes, improved HRQoL, and had a favorable safety profile.
Keywords
American Urogynecologic Society
SER120
desmopressin
nocturia
nocturnal polyuria
overactive bladder
clinical trials
health-related quality of life
safety
tolerability