Treatment with Noctiva Nasal Spray (desmopressin acetate; Avadel), approved for nocturia in adults due to nocturnal polyuria, demonstrated a significant reduction in the number of nocturic voids (NOV) among older adults and an extended first uninterrupted sleep period (FUSP), according to new findings announced by Avadel. Findings were presented at the International Continence Society (ICS) Meeting.
Data from the phase 3 clinical trials of Noctiva included an analysis of two Phase 3 trials that included a total of 1045 patients with nocturia due to nocturnal polyuria.
In one analysis of FUSP, patients were randomized to receiver Noctiva 1.66mcg, Noctiva 0.83mcg or placebo for 12 weeks. Sub-group analyses of patients aged ≥65 years and ≥75 years showed that the mean FUSP was extended to >4 hours for the Noctiva 1.66mcg group, and ~4 hours for the Noctiva 0.83mcg group. Also, these patients had a statistically significant reduction in nocturic episodes.
Another analysis found that after the first dose (Noctiva 1.66mcg, 0.83mcg or placebo), Noctiva-treated patients had a significantly greater mean reduction in NOV and longer FUSP vs placebo. This finding showed the rapid onset of effect with efficacy following the first dose. Noctiva was a.so well-tolerated for the length of the study.
“These studies indicate that treating nocturia in older patients prolongs sleep and improves how patients feel and function during the day,” said Benjamin M. Brucker, MD, urologist and director of the Center of Female Pelvic Medicine at New York University’s Langone Health.
Noctiva, a vasopressin analog, is a proprietary emulsified formulation that provides a microdose of desmopressin; it was the first approved product to treat nocturia in adults due to nocturnal polyuria. It is available as 0.83mcg and 1.66mcg strength nasal sprays containing 30 effective doses each.
For more information visit FDA.gov.