E-Posters-Extended First Uninterrupted Sleep Period in Nocturia Patients with Nocturnal Polyuria Following Treatment with AV002, an Emulsified Microdose Vasopressin Analog Nasal Spray for Nocturia

Extended First Uninterrupted Sleep Period in Nocturia Patients with Nocturnal Polyuria Following Treatment with AV002, an Emulsified Microdose Vasopressin Analog Nasal Spray for Nocturia - Sangeeta Mahajan, MD

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A study presented at PFD Week 2018 evaluated the efficacy and safety of an emulsified microdose desmopressin nasal spray (AV002) in patients with nocturia due to nocturnal polyuria (NP). The study found that AV002 significantly increased the length of the first uninterrupted sleep period (FUSP) and improved quality of life (QoL) compared to placebo. Both doses of AV002 (1.66 mcg and 0.83 mcg) showed a greater percentage of patients achieving ≥4 hours of FUSP compared to placebo. The 1.66 mcg dose of AV002 increased FUSP approximately 1.6 times over placebo. Data also indicated an association between increased FUSP and improved QoL. The incidence of patients with a low serum sodium level following AV002 treatment was low, with no patients in the 0.83 mcg treatment group having severe hyponatremia. The study concluded that AV002 is a safe and effective therapy for patients with NP.<br /><br />Nocturia is a common condition associated with disrupted sleep and reduced productivity. NP is present in approximately 80% of patients with nocturia. Restorative sleep occurs during the first 3 to 4 hours of sleep, and increasing the length of FUSP may improve QoL. AV002, an antidiuretic, is an effective therapy for nocturia due to nocturnal polyuria.<br /><br />The study analyzed data from 2 phase 3 clinical trials involving 1045 patients with NP. Both doses of AV002 significantly increased the percentage of patients with ≥4 hours of FUSP. The safety profile of AV002, in terms of serum sodium levels, was generally favorable, with a low incidence of patients experiencing a low serum sodium level. The study also assessed QoL using the Impact of Nighttime Urination (INTU) questionnaire and found that both doses of AV002 improved patients' overall functioning and feelings.<br /><br />In conclusion, AV002 showed a significant increase in FUSP and improvement in QoL in patients with NP. The incidence of low serum sodium levels following AV002 treatment was low. AV002 is considered a safe and effective therapy for patients with NP.

Keywords

PFD Week 2018

emulsified microdose desmopressin nasal spray

nocturia

nocturnal polyuria

first uninterrupted sleep period

quality of life

placebo

serum sodium level

hyponatremia

clinical trials