Rapid Nocturia Efficacy of AV002, an Emulsified Microdose Vasopressin Analog

Campeau L1, Yang A2, Francis L2, Newman D K3

Research Type

Clinical

Abstract Category

Nocturia

Abstract 18
Nocturia
Scientific Podium Short Oral Session 2
Wednesday 29th August 2018
09:57 - 10:05
Hall B
Nocturia Quality of Life (QoL) Voiding Dysfunction Overactive Bladder Benign Prostatic Hyperplasia (BPH)
1. McGill University, 2. Avadel Specialty Pharmaceuticals, LLC., 3. Perelman School of Medicine, University of Pennsylvania
Presenter
L

Lysanne Campeau

Links

Abstract

Hypothesis / aims of study
Nocturia is a highly prevalent, under-recognized condition associated with disrupted sleep, reduced productivity, and negative impacts on overall health and health-related quality of life. Oftentimes, it is unclear whether a therapy is effective for nocturia given the lengthy time to confirm responsiveness, if at all. Hence, the rapidity of effect on nocturia is of keen interest. ≥2 nocturic voids (NOVs) is associated with decreased quality of life. Achieving a reduction of 0.5 NOVs is clinically significant. First uninterrupted sleep period (FUSP) is defined as the time from bedtime to first nocturic void or awakening if no void occurred. The first 3-4 hours of sleep includes deep, slow wave, restorative sleep, which is correlated with improved productivity. AV002 is an emulsified microdose vasopressin analog nasal spray approved for the treatment of nocturia due to nocturnal polyuria. The effect of the first dose of AV002 on the number of NOV and FUSP were assessed in patients in two Phase 3 randomized, double-blind pivotal studies.
Study design, materials and methods
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 first dose, 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).
Results
After 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.
Interpretation of results
After first dose, patients treated with AV002 demonstrated 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.
Concluding message
Rapidly addressing nocturia after first dose enables clinicians and patients to quickly confirm responsiveness while providing confidence in ongoing therapy.
Figure 1
References
  1. Bliwise DL, Foley DJ, Vitiello MV, Ansari FP, Ancoli-Israel S, Walsh JK. Nocturia and Disturbed Sleep in the Elderly. Sleep Med. 2009 May; 10(5):540-548.
  2. Stanley N. The Underestimated Impact of Nocturia on Quality of Life. Eur Urol Suppl. 2005;4(7):17-19.
  3. Bosch JLH, Weiss JP. The prevalence and causes of nocturia. J Urol. 2010;184(2):440-446.
Disclosures
Funding Avadel Specialty Pharmaceuticals, LLC. Clinical Trial Yes Registration Number U.S. National Library of Medicine, NCT01357356 and NCT01900704 RCT Yes Subjects Human Ethics Committee Western Institutional Review Board Helsinki Yes Informed Consent Yes