FDA-Approved Treatment for Nocturia Due to Nocturnal Polyuria Launched

Avadel announced that Noctiva (desmopressin acetate) nasal spray is available for the treatment of nocturia due to nocturnal polyuria in adults who awaken ≥2 times a night to void. Nocturnal polyuria was defined in clinical trials as nighttime urine production exceeding one-third of the 24-hour urine production.

Noctiva was approved by the Food and Drug Administration (FDA) in March 2017 based on findings from two 12-week, randomized, double-blind, placebo-controlled trials (N=1045) in patients with nocturia due to nocturnal polyuria. It contains an emulsified microdose of desmopressin acetate combined with a permeation enhancer that increases the transport of the drug across the nasal mucosa. Desmopressin, a synthetic analogue of vasopressin, is a selective agonist at V2 receptors on renal cells in the collecting ducts, increasing water re-absorption in the kidneys, and reducing urine production.

Noctiva is supplied as a nasal spray in two strengths: 0.83mcg/0.1mL and 1.66mcg/0.1mL. Each bottle contains 30 effective doses in addition to the initial priming (5 actuations) which is equal to 30 days of medication when used as one spray once a day.

Clinicians should ensure that serum sodium is normal before starting or resuming treatment with Noctiva. Serum sodium should be measured within seven days and approximately one month after starting therapy or increasing the dose, and periodically during treatment. Patients 65 years of age and older and those with increased risk of hyponatremia should be monitored more frequently. If hyponatremia occurs, Noctiva may need to be temporarily or permanently discontinued.

For more information call (877) 638-4579 or visit Noctiva.com.