E-Posters-Increase in Percentage of Nights with Nocturic Voids per Night in Nocturia Patients with Nocturnal Polyuria Following Treatment with AV002, an Emulsified Microdose Vasopressin Analog Nasal Spray for Nocturia

Increase in Percentage of Nights with Nocturic Voids per Night in Nocturia Patients with Nocturnal Polyuria Following Treatment with AV002, an Emulsified Microdose Vasopressin Analog Nasal Spray for Nocturia - Kathleen C. Kobashi, MD

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A study presented at PFD Week 2018 evaluated the efficacy and tolerability of AV002, an emulsified microdose desmopressin nasal spray, for the treatment of nocturia in patients with nocturnal polyuria (NP). The study included a pooled analysis of two phase 3 clinical trials involving 1045 patients.<br /><br />The results showed that AV002 significantly increased the percentage of nights with ≤1 nocturic void and 0 nocturic void on a per patient basis. The 1.66 mcg dose of AV002 caused a more than double increase in nights with no voids compared to placebo. AV002 also significantly increased the percentage of patients with ≥50% reduction in nocturic voids and significantly reduced nocturnal urine volume in NP patients.<br /><br />The tolerability profile of AV002 was generally well-tolerated. The most common event was nasal discomfort. There was a low incidence of serum sodium below the normal range, with chronic steroid treatment contributing to most cases.<br /><br />Nocturia is a bothersome lower urinary tract symptom that affects the quality of life of patients. Nocturnal polyuria is present in about 80% of patients with nocturia. AV002 has shown to be an effective therapy for patients with NP.<br /><br />In summary, AV002, an emulsified microdose desmopressin nasal spray, was found to be a well-tolerated and effective therapy for patients with NP. It significantly increased the percentage of nights with ≤1 and 0 nocturic voids on a per patient basis, as well as the percentage of patients with ≥50% reduction in nocturic voids and reduced nocturnal urine volume.

Keywords

PFD Week 2018

AV002

emulsified microdose desmopressin nasal spray

nocturia

nocturnal polyuria

phase 3 clinical trials

nocturic voids

placebo

nocturnal urine volume

tolerability profile