“AV-002 has been engineered to provide immediate onset of action and a predictable duration using the lowest effective dose to mitigate the risk of hyponatremia. The findings from the age-based analyses of the phase III study data give me confidence to talk to older patients about nocturia knowing that I can now offer them safe and effective therapy," Dr. Brucker said.
He added that data collected in the phase III studies also showed that treatment with AV-002 was associated with statistically significant improvements in quality of life and patient-reported impact of nocturia outcomes in the overall population.
“The data from these questionnaires are now being analyzed with patients stratified by age, and I have no doubt that the results will show consistent benefits in the older age group,” Dr. Brucker told Urology Times.
To be eligible for participation in the AV-002 phase III studies, patients had to be ≥50 years of age and have a history of ≥2 nocturic voids per night for 6 months. In total, 1,333 patients were randomized into three treatment arms to receive AV-002, 0.83 mcg; AV-002, 1.66 mcg; or placebo nightly for 12 weeks. The overall population included 727 patients aged ≥65 years and 292 patients aged ≥75 years.
The mean first uninterrupted sleep period across all treatment arms in all age groups was 2.4 to 2.5 hours at baseline and was consistently extended at the end of the study by 1.3 to 1.7 hours with either dose of AV-002 in all age groups.
“The first uninterrupted sleep period is a critically important measure when talking about nocturia because it is during the first 3 to 4 hours of sleep when patients get the deep, slow-wave restorative sleep that is critical for good daytime function and productivity,” said Dr. Brucker.
“Patients of all ages were reaching this threshold after starting treatment with either dose of AV-002.”