Nocturia treatment efficacious after single dose

AV002, an emulsified microdose desmopressin acetate nasal spray (Noctiva) indicated for nocturia due to nocturnal polyuria, demonstrated efficacy after just one dose, data from pivotal clinical trials show.

Following the first dose, the mean number of nocturic episodes decreased, and the length of the first undisturbed sleep period increased, according to the analysis of patients enrolled in phase III randomized, double-blind studies.

No cases of severe hyponatremia were observed in patients treated at the lower 0.83-mcg dose that is recommended as the starting dose for patients 65 years of age or older, investigator Diane Newman, DNP, said at the International Continence Society annual meeting in Philadelphia.

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“The results suggest that this compound has rapid efficacy and a favorable safety profile in patients with nocturia due to nocturnal polyuria,” said Dr. Newman, of the Penn Center for Continence and Pelvic Health in the division of urology at the University of Pennsylvania Medical Center, Philadelphia.

The two phase III studies included 1,333 patients 50 years of age or older who had a history of at least two nocturic voids nightly for at least 6 months.

Patients were randomly assigned to a high dose of AV002 (1.66 mcg), a low dose (0.83 mcg), or placebo, and received 12 weeks of treatment. The mean age of the patients was approximately 66 years, and about 57% were male.

After the first dose, the mean change in nocturic episodes was–1.0 for placebo, –1.2 for the lower AV002 dose, and –1.4 for the higher dose (p≤.05 compared to placebo), Dr. Newman reported.

Next:First uninterrupted sleep period increased after one doseAchieving a reduction of 0.5 nocturic voids is clinically significant, Dr. Newman and co-investigators said in an abstract accompanying their presentation.

The length of the first uninterrupted sleep period likewise increased after one dose, at a mean of 0.9 hours for placebo, and 1.5 hours for both the low and high doses of AV002 (p≤.05 compared to placebo), the data show.

Efficacy was sustained to week 12, including statistically significant reductions in nocturic episodes and increases in first uninterrupted sleep period for both doses of AV002 versus placebo.

For patients receiving the highest dose, the total first uninterrupted sleep period exceeded 4 hours.

“The concept here is that the longer you sleep, the more restorative it will be, especially if you get to 4 hours,” Dr. Newman told ICS attendees at the scientific session where she presented the results.

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AV002 was approved by the FDA in March 2017 for treatment of nocturia in adults due to nocturnal polyuria. The prescribing information includes a boxed warning that the nasal spray can cause hyponatremia, which may be life-threatening if severe.

In the phase III trial data presented by Dr. Newman, severe hyponatremia, defined as ≤125 mmol/L, was seen in one patient who received placebo (0.2%), no patients on the lower AV002 dose, and five patients on the higher dose (1.1%).

Some of the most common treatment-emergent side effects included nasal discomfort in 3.5% and 5.6% of the low- and high-dose AV002 groups, respectively, as well as nasopharyngitis, which was seen in 3.1% and 3.8% of those groups, she said.

The study was funded by Serenity Pharmaceuticals, LLC. Dr. Newman reported consulting with Serenity Pharmaceuticals.