Efficacy outcomes and adverse-event data from two phase III pivotal trials supported the FDA decision to approve AV-002, an emulsified microdose desmopressin acetate nasal spray (Noctiva), as the first treatment for nocturia due to nocturnal polyuria in adults who awaken at least two times per night to void.
Speaking at the AUA annual meeting in San Francisco, Benjamin M. Brucker, MD, of New York University Langone Health, New York, reported new analyses demonstrating that the benefits and safety of AV-002 treatment are the same in elderly patients compared with the overall enrolled population that included adults aged ≥50 years.
Analyses with patients stratified into three groups by age (≥50, ≥65, and ≥75 years) showed that AV-002 consistently extended the first uninterrupted sleep period in a clinically meaningful manner for patients of all ages. The percentage of patients experiencing one or fewer nocturic voids per night also increased consistently in all age groups. The safety review showed there were no cases of severe hyponatremia among patients ≥65 years treated with AV-002, 0.83 mcg, which is the recommended starting dose for this older age group.
“Nocturia is a condition that affects people of all ages and has many negative consequences, but previously available desmopressin preparations did not work as well in older patients and had a poorer safety profile,” Dr. Brucker told Urology Times.