This late-breaking clinical trial presentation discusses the effects of drug AV002 (NOCTIVA) in men and women 50 years of age and older with a diagnosis of nocturia and nocturnal polyuria. Researchers were interested to explore if medication would allow people to extend the time between falling asleep at bedtime and their first nighttime void or their first awakening or first uninterrupted sleep period (FUSP). The first 3-4 hours of sleep are of outmost importance because they are considered restorative, which is correlated to daytime productivity. Nocturia is known to interfere with FUSP and result in sleep deprivation and overall decrease in QoL.
Phase 3, randomized, double blind studies were conducted to assess safety and efficacy of AV002 (NOCTIVA) in people ≥65 and ≥75 years of age. This particular population has a higher risk of adverse events with older desmopressin formulations. This nasal spray formulation offers the lowest dose of desmopressin and provides immediate relief of symptoms that reduces urine production for a predictable for 4-6 hours.
None of the participants were instructed to modify their diet or fluid intake. Eligible subjects received 0.83 mcg, 1.66 mcg, or placebo during three months. Primary endpoints included the duration of the first uninterrupted sleep period and the number of nights with one or less nocturic episodes compared to baseline information.
AV002 safety assessment included analysis of adverse events and cases of hyponatremia. Moderate hyponatremia was defined as 126-129 mmol/L, and severe hyponatremia constituted serum sodium level of ≤125 mmol/L.
These ITT results demonstrated that this desmopressin formulaiton was effective in prolonging FUSP and reducing nocturic voids to one or fewer episodes (Figure 1).
Data demonstrates that FUSP was significantly increased in participants of both groups. It was increased to 4 hours for both doses compared to placebo.
Subjects also reported about 50% of nights with one or less voids (Figure 2).
Although hyponatremia was reported in some research patients in this overall study population, incidence was low for both doses.
AV002 could be recommended for the patients with nocturia and is the only FDA approved treatment that is safe and effective. There were no reports of severe adverse events related to the drug in patients who took the lowest dose of medication (0.83 mcg). This dose can be ideal therapy options for the studied cohort.
Presented by: Benjamin Brucker, MD, New York University
Co-Authors: Eric S. Rovner, Charleston, SC., Leo Francis, Alex Yang, Chesterfield, MO.
Written by: Hanna Stambakio, BS, Clinical Research Coordinator, Division of Urology,, University of Pennsylvania, @PennUrology at the 2018 AUA Annual Meeting - May 18 - 21, 2018 – San Francisco, CA USA