Poster #50: Extended First Uninterrupted Sleep Period in Nocturia Patients with Nocturnal Polyuria Following Treatment with AV002, an Emulsified Microdose Vasopressin Analog Nasal Spray for Nocturia
The efficacy of NOCTIVA on FUSP and safety, as secondary endpoints, were evaluated in patients age 50 years and older with nocturia due to nocturnal polyuria in two Phase 3 randomized, double-blind pivotal studies. FUSP is defined as elapsed time from bedtime to first NOV or awakening if no void occurred. Patients were randomized into three groups and received either 1.66 mcg or 0.83 mcg of NOCTIVA, or a placebo for 12 weeks. The baseline average FUSP for all groups was 2.4 hours.
In the NOCTIVA 1.66 mcg group, FUSP increased by 1.8 hours to 4.2 hours, and in the NOCTIVA 0.83 mcg group, FUSP increased by 1.6 hours to 4.0 hours, which was statistically significant compared to placebo. Incidence and severity of adverse events were similar to placebo, and the incidence of hyponatremia, defined as serum sodium ≤125 mmol/L regardless of symptoms or <130 mmol/L with symptoms, was low for both doses. No patients treated with 0.83 mcg experienced serum sodium ≤125 mmol/L. These results demonstrate that NOCTIVA is an effective therapy with a well-tolerated safety profile in patients with nocturia due to nocturnal polyuria and may provide longer periods of uninterrupted sleep.
Poster #51: Increase in Percentage of Nights with ≤ 1 Nocturic Void per Night in Nocturia Patients with Nocturnal Polyuria Following Treatment with AV002, an Emulsified Microdose Vasopressin Analog Nasal Spray for Nocturia
In two Phase 3 randomized, double-blind pivotal studies, the efficacy of NOCTIVA on percentage of nights with one to zero NOVs, and a secondary endpoint of safety, were assessed in patients age 50 years and older with nocturia due to nocturnal polyuria. Zero to one NOV per night is considered normal. Patients were randomized into three groups and received either 1.66 mcg or 0.83 mcg of NOCTIVA, or a placebo for 12 weeks. At baseline for all study participants, the average number of nights with one or no NOVs was only one percent (calculated on a per-patient basis for six out of 14 nights).
In the NOCTIVA treatment groups, the percentage of nights with one to zero NOVs increased from one percent to 45 percent for 1.66 mcg group, and to 41 percent for 0.83 mcg group, which was statistically significant compared to placebo. Incidence and severity of adverse events were similar to placebo, and the incidence of hyponatremia, defined as serum sodium ≤125 mmol/L regardless of symptoms or <130 mmol/L with symptoms, was low for both doses. No patients treated with 0.83 mcg experienced serum sodium ≤125 mmol/L. These results show that NOCTIVA is an effective therapy with a well-tolerated safety profile in patients with nocturia due to nocturnal polyuria.
“Disturbance of restorative sleep can have serious consequences on your health and quality of life. Returning to normal levels of nighttime voids is key to improving quality of sleep and function during the day. These studies demonstrate that NOCTIVA is an effective therapy with a well-tolerated safety profile for patients suffering with nocturia due to nocturnal polyuria,” said Kathleen C. Kobashi, Department of Urology, Virginia Mason Medical Center, Seattle, Washington.