ICS 2018: Efficacy of AV002, an Emulsified Microdose Vasopressin Analog for Rapid Nocturia

Philadelphia, PA (UroToday.com) Diane K. Newman and colleagues assessed the effect of the first dose of AV002 on the number of NOV and FUSP in patients in two Phase 3 randomized, double-blind pivotal studies.

Patients ≥50 years old with a history of ≥2 NOVs per night for ≥6 months (n=1333) were randomized to AV002 1.66mcg, AV002 0.83mcg, or placebo and treated for 12 weeks. After the first dose, the number of NOV and FUSP were measured. Safety evaluations included adverse events (AEs) and incidence of hyponatremia (moderate: 126-129 mmol/L; severe: ≤125 mmol/L).

After the first dose, reduction in NOV and increase in FUSP from baseline were significant in both treatment groups (Table 1). Throughout the study, incidence and severity of AEs in AV002-treated groups were similar to placebo. The incidence of hyponatremia was low for both doses.
UroToday ICS2018 6. Efficacy of AV002 an Emulsified Microdose Mean Reduction in Nocturic Voids

After the first dose, patients treated with AV002 demonstrated a significant reduction of nocturic voids and improvement in duration of first uninterrupted sleep period. These results suggest AV002 has rapid efficacy with a favorable safety profile in patients with nocturia due to nocturnal polyuria.

UroToday ICS2018 Efficacy of AV002 an Emulsified Microdose

In conclusion rapidly addressing nocturia after the first dose enables clinicians and patients to quickly confirm responsiveness while providing confidence in ongoing therapy.

Presented by Diane Newman, DNP, ANP-BC, FAAN, Adjunct Professor of Urology in Surgery, Perelman School of Medicine, University of Pennsylvania.Co-Authors: Campeau L1, Yang A2, Francis L2
1. McGill University, 2. Avadel Specialty Pharmaceuticals, LLC.

Written by: Bilal Farhan, MD; Clinical Instructor, Female Pelvic Medicine and Reconstructive Surgery, University of California, Irvine Medical Center, Twitter: @Bilalfarhan79 at the 2018 ICS International Continence Society Meeting - August 28 - 31, 2018 – Philadelphia, PA USA